---
title: Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes
nct_id: NCT00799448
overall_status: TERMINATED
phase: PHASE4
sponsor: Novo Nordisk A/S
study_type: INTERVENTIONAL
primary_condition: Diabetes
countries: Greece
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00799448.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00799448"
ct_last_update_post_date: 2017-02-20
last_seen_at: "2026-05-12T06:44:32.815Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes

**Official Title:** Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone

**NCT ID:** [NCT00799448](https://clinicaltrials.gov/study/NCT00799448)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Low recruitment status
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Novo Nordisk A/S
- **Conditions:** Diabetes, Diabetes Mellitus, Type 2
- **Start Date:** 2003-09-16
- **Completion Date:** 2004-09-20
- **CT.gov Last Update:** 2017-02-20

## Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* HbA1c: 7.5-11.0% on current therapy
* OHA (oral hypoglycaemic agent) treatment for a minimum of two years
* BMI (body mass index): 25-32 kg/m2
```

## Interventions

- **repaglinide** (DRUG)
- **biphasic human insulin 30** (DRUG)
- **insulin NPH** (DRUG)

## Primary Outcomes

- **HbA1c** _(time frame: after 20 weeks of treatment)_

## Secondary Outcomes

- **Fasting blood glucose (FBG)**
- **Incidence of hypoglycaemic episodes**
- **Adverse events**

## Locations (1)

- Novo Nordisk Investigational Site, Athens, Greece

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — 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.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — 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|athens||greece` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00799448.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00799448*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*