---
title: Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
nct_id: NCT00456027
overall_status: COMPLETED
phase: PHASE2
sponsor: Diamyd Therapeutics AB
study_type: INTERVENTIONAL
primary_condition: Latent Autoimmune Diabetes in Adult (LADA)
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00456027.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00456027"
ct_last_update_post_date: 2011-06-10
last_seen_at: "2026-05-12T07:02:48.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)

**Official Title:** A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)

**NCT ID:** [NCT00456027](https://clinicaltrials.gov/study/NCT00456027)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 160
- **Lead Sponsor:** Diamyd Therapeutics AB
- **Conditions:** Latent Autoimmune Diabetes in Adult (LADA)
- **Start Date:** 2004-12
- **Completion Date:** 2008-04
- **CT.gov Last Update:** 2011-06-10

## Brief Summary

This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Key Inclusion Criteria:

* Male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years
* Presence of GAD65 antibodies
* Detectable C-peptide level
* Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA)
* Written informed Consent

Key Exclusion Criteria:

* Treatment with insulin
* Intolerance to OHA
* Secondary diabetes mellitus
* History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, HIV, hepatitis)
* Treatment with any vaccine within one month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* Pregnancy (or planned pregnancy within one year after 2nd administration)
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
* Significant illness other than diabetes within 2 weeks prior to first dosing
* Unwillingness to comply with the provisions of the protocol
* Clinically significant history of acute reaction to drugs in the past
* Treatment with immunosuppressants
```

## Interventions

- **rhGAD65 formulated in Alhydrogel® (Diamyd®)** (DRUG) — 20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart

## Primary Outcomes

- **The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement.** _(time frame: 30 months)_

## Locations (17)

- Alingsås Hospital, Alingsås, Sweden
- Falu Hospital, Falun, Sweden
- Capio Lundby Hospital, Gothenburg, Sweden
- Härnösand Hospital, Härnösand, Sweden
- Helsingborg Hospital, Helsingborg, Sweden
- Karlstad Central Hospital, Karlstad, Sweden
- Central Hospital, Kristianstad, Kristianstad, Sweden
- Sunderby Hospital, Luleå, Sweden
- University Hospital MAS, Malmö, Sweden
- Vrinnevi Hospital, Norrköping, Sweden
- Odensala Health Clinic, Östersund, Sweden
- Skellefteå Hospital, Skellefteå, Sweden
- S:t Göran Hospital, Stockholm, Sweden
- Stockholm South General Hospital, Stockholm, Sweden
- Norrlands University Hospital, Umeå, Sweden
- Uppsala University Hospital, Uppsala, Sweden
- Växjö Central Hospital, Vaxjo, Sweden

## 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.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.alingsås hospital|alingsås||sweden` — added _(2026-05-12)_
- `locations.falu hospital|falun||sweden` — added _(2026-05-12)_
- `locations.capio lundby hospital|gothenburg||sweden` — added _(2026-05-12)_
- `locations.härnösand hospital|härnösand||sweden` — added _(2026-05-12)_
- `locations.helsingborg hospital|helsingborg||sweden` — added _(2026-05-12)_
- `locations.karlstad central hospital|karlstad||sweden` — added _(2026-05-12)_
- `locations.central hospital, kristianstad|kristianstad||sweden` — added _(2026-05-12)_
- `locations.sunderby hospital|luleå||sweden` — added _(2026-05-12)_
- `locations.university hospital mas|malmö||sweden` — added _(2026-05-12)_
- `locations.vrinnevi hospital|norrköping||sweden` — added _(2026-05-12)_
- `locations.odensala health clinic|östersund||sweden` — added _(2026-05-12)_
- `locations.skellefteå hospital|skellefteå||sweden` — added _(2026-05-12)_
- `locations.s:t göran hospital|stockholm||sweden` — added _(2026-05-12)_
- `locations.stockholm south general hospital|stockholm||sweden` — added _(2026-05-12)_
- `locations.norrlands university hospital|umeå||sweden` — added _(2026-05-12)_
- `locations.uppsala university hospital|uppsala||sweden` — added _(2026-05-12)_
- `locations.växjö central hospital|vaxjo||sweden` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00456027.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00456027*  
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