--- title: Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes nct_id: NCT00978627 overall_status: COMPLETED phase: PHASE3 sponsor: Novo Nordisk A/S study_type: INTERVENTIONAL primary_condition: Diabetes countries: United States, Australia, Denmark, France, Israel, Poland, Puerto Rico, Romania, Russia, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00978627.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00978627" ct_last_update_post_date: 2017-03-20 last_seen_at: "2026-05-12T07:02:31.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes **Official Title:** NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1) **NCT ID:** [NCT00978627](https://clinicaltrials.gov/study/NCT00978627) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 548 - **Lead Sponsor:** Novo Nordisk A/S - **Conditions:** Diabetes, Diabetes Mellitus, Type 1 - **Start Date:** 2009-08 - **Completion Date:** 2010-05 - **CT.gov Last Update:** 2017-03-20 ## Brief Summary This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * FOR THE MAIN TRIAL, NN5401-3594: * Type 1 diabetes mellitus for at least 12 months * Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months * HbA1c 7.0-10.0% (both inclusive) * BMI (Body Mass Index) below or equal to 35.0 kg/m\^2 * FOR THE EXTENSION TRIAL, NN5401-3645: * The subject must have completed the six-month treatment period in trial NN5401-3594 Exclusion Criteria: * FOR THE MAIN TRIAL, NN5401-3594: * Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months * Cardiovascular disease within the last 6 months * Uncontrolled treated/untreated severe hypertension * Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * Cancer and medical history of cancer * FOR THE EXTENSION TRIAL, NN5401-3645: * Anticipated significant lifestyle changes during the trial * Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures ``` ## Arms - **IDegAsp OD** (EXPERIMENTAL) - **IDet** (ACTIVE_COMPARATOR) ## Interventions - **insulin degludec/insulin aspart** (DRUG) — Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted. - **insulin detemir** (DRUG) — Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted. - **insulin aspart** (DRUG) — Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted. - **insulin aspart** (DRUG) — Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted. ## Primary Outcomes - **Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment** _(time frame: Week 0, Week 26)_ — Change from baseline in HbA1c after 26 weeks of treatment - **Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes** _(time frame: Week 0 to Week 53 + 7 days follow up)_ — Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L. - **Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes** _(time frame: Week 0 to Week 53 + 7 days follow up)_ — Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. - **Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)** _(time frame: Week 0 to Week 53 + 7 days of follow up)_ — Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. ## Secondary Outcomes - **Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes** _(time frame: Week 0 to Week 26 + 7 days follow up)_ - **Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26** _(time frame: Week 26)_ - **Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment** _(time frame: Week 0, Week 53)_ - **Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes** _(time frame: Week 0 to Week 26 + 7 days follow up)_ - **Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment** _(time frame: Week 0, Week 53)_ ## Locations (81) - Novo Nordisk Investigational Site, La Mesa, California, United States - Novo Nordisk Investigational Site, Lancaster, California, United States - Novo Nordisk Investigational Site, Mission Hills, California, United States - Novo Nordisk Investigational Site, North Hollywood, California, United States - Novo Nordisk Investigational Site, Salinas, California, United States - Novo Nordisk Investigational Site, Valencia, California, United States - Novo Nordisk Investigational Site, Aurora, Colorado, United States - Novo Nordisk Investigational Site, Miami, Florida, United States - Novo Nordisk Investigational Site, Miami, Florida, United States - Novo Nordisk Investigational Site, Atlanta, Georgia, United States - Novo Nordisk Investigational Site, Lawrenceville, Georgia, United States - Novo Nordisk Investigational Site, Roswell, Georgia, United States - Novo Nordisk Investigational Site, Honolulu, Hawaii, United States - Novo Nordisk Investigational Site, Chicago, Illinois, United States - Novo Nordisk Investigational Site, Shawnee Mission, Kansas, United States - Novo Nordisk Investigational Site, Lexington, Kentucky, United States - Novo Nordisk Investigational Site, Eagan, Minnesota, United States - Novo Nordisk Investigational Site, Minneapolis, Minnesota, United States - Novo Nordisk Investigational Site, City of Saint Peters, Missouri, United States - Novo Nordisk Investigational Site, Butte, Montana, United States - Novo Nordisk Investigational Site, Omaha, Nebraska, United States - Novo Nordisk Investigational Site, Henderson, Nevada, United States - Novo Nordisk Investigational Site, Albany, New York, United States - Novo Nordisk Investigational Site, Northport, New York, United States - Novo Nordisk Investigational Site, Morehead City, North Carolina, United States - Novo Nordisk Investigational Site, Greer, South Carolina, United States - Novo Nordisk Investigational Site, Dallas, Texas, United States - Novo Nordisk Investigational Site, San Antonio, Texas, United States - Novo Nordisk Investigational Site, San Antonio, Texas, United States - Novo Nordisk Investigational Site, Seattle, Washington, United States - Novo Nordisk Investigational Site, Broadmeadow, New South Wales, Australia - Novo Nordisk Investigational Site, Camperdown, New South Wales, Australia - Novo Nordisk Investigational Site, Coffs Harbour, New South Wales, Australia - Novo Nordisk Investigational Site, Keswick, South Australia, Australia - Novo Nordisk Investigational Site, Box Hill, Victoria, Australia - Novo Nordisk Investigational Site, Fitzroy, Australia - Novo Nordisk Investigational Site, Geelong, Australia - Novo Nordisk Investigational Site, Aalborg, Denmark - Novo Nordisk Investigational Site, Århus C, Denmark - Novo Nordisk Investigational Site, Gentofte Municipality, Denmark - Novo Nordisk Investigational Site, Auxerre, France - Novo Nordisk Investigational Site, Narbonne, France - Novo Nordisk Investigational Site, Nîmes, France - Novo Nordisk Investigational Site, Pointe à Pitre, France - Novo Nordisk Investigational Site, Petah Tikva, Israel - Novo Nordisk Investigational Site, Rishon LeZiyyon, Israel - Novo Nordisk Investigational Site, Tel Litwinsky, Israel - Novo Nordisk Investigational Site, Lodz, Poland - Novo Nordisk Investigational Site, Lodz, Poland - Novo Nordisk Investigational Site, Sopot, Poland - Novo Nordisk Investigational Site, Szczecin, Poland - Novo Nordisk Investigational Site, Warsaw, Poland - Novo Nordisk Investigational Site, Warsaw, Poland - Novo Nordisk Investigational Site, Bayamón, Puerto Rico - Novo Nordisk Investigational Site, Brasov, Brașov County, Romania - Novo Nordisk Investigational Site, Buzău, Buzău, Romania - Novo Nordisk Investigational Site, Cluj-Napoca, Cluj, Romania - Novo Nordisk Investigational Site, Bucharest, Romania - Novo Nordisk Investigational Site, Bucharest, Romania - Novo Nordisk Investigational Site, Iași, Romania - Novo Nordisk Investigational Site, Oradea, Romania - Novo Nordisk Investigational Site, Sibiu, Romania - Novo Nordisk Investigational Site, Kemerovo, Russia - Novo Nordisk Investigational Site, Kursk, Russia - Novo Nordisk Investigational Site, Moscow, Russia - Novo Nordisk Investigational Site, Moscow, Russia - Novo Nordisk Investigational Site, Penza, Russia - Novo Nordisk Investigational Site, Saint Petersburg, Russia - Novo Nordisk Investigational Site, Samara, Russia - Novo Nordisk Investigational Site, Saratov, Russia - Novo Nordisk Investigational Site, Saratov, Russia - Novo Nordisk Investigational Site, Smolensk, Russia - Novo Nordisk Investigational Site, Volgograd, Russia - Novo Nordisk Investigational Site, Bristol, United Kingdom - Novo Nordisk Investigational Site, Dundee, United Kingdom - Novo Nordisk Investigational Site, Edinburgh, United Kingdom - Novo Nordisk Investigational Site, Leicester, United Kingdom - Novo Nordisk Investigational Site, Liverpool, United Kingdom - Novo Nordisk Investigational Site, Oxford, United Kingdom - Novo Nordisk Investigational Site, Salford, United Kingdom - Novo Nordisk Investigational Site, Wirral, Merseyside, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|la mesa|california|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|lancaster|california|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|mission hills|california|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|north hollywood|california|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|salinas|california|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|valencia|california|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|miami|florida|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|lawrenceville|georgia|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|roswell|georgia|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|honolulu|hawaii|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|shawnee mission|kansas|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|lexington|kentucky|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|eagan|minnesota|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|city of saint peters|missouri|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|butte|montana|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|henderson|nevada|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|albany|new york|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|northport|new york|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|morehead city|north carolina|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|greer|south carolina|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|dallas|texas|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|seattle|washington|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|broadmeadow|new south wales|australia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|camperdown|new south wales|australia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|coffs harbour|new south wales|australia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|keswick|south australia|australia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|box hill|victoria|australia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|fitzroy||australia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|geelong||australia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00978627.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00978627* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*