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Completed Phase 2 Interventional

A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

ClinicalTrials.gov ID: NCT00423501

Public ClinicalTrials.gov record NCT00423501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Study identification

NCT ID
NCT00423501
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
306 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2007
Primary completion
Oct 31, 2007
Completion
Oct 31, 2007
Last update posted
Nov 1, 2016

2007

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Not listed Washington D.C. District of Columbia 20010
Not listed Woodstock Georgia 30189
Not listed Chicago Illinois 60607
Not listed Springfield Illinois 62704-1433
Not listed Rochester New York 14609
Not listed Portland Oregon 97239
Not listed Dallas Texas 75246
Not listed Midland Texas 79707
Not listed San Antonio Texas 78229
Not listed Richmond Virginia 23249

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00423501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2016 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00423501 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →