Not Signed In -
Insulin glargine |
insulin glargine [rDNA origin]; Lantus |
Clinical Trial: Effects of Exenatide and Insulin Glargine in Subjects with Type 2 Diabetes
This study is currently recruiting patients.
|
Purpose
This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: exenatide Drug: Insulin glargine | Phase III |
MedlinePlus related topics: Diabetes
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Randomized, Open Label, Comparator Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects with Type 2 Diabetes Treated with Metformin who have not Achieved Target HbA1c (<=7.0%)
Eligibility
Ages Eligible for Study: 30 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- HbA1c between 7.1% and 9.5%, inclusive.
- Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
- Treated with a stable dose of metformin for at least 3 months prior to screening.
Exclusion Criteria:
- Patients previously in a study using exenatide.
- Treated with oral anti-diabetic medications other than metformin within 3 months of screening.
- Treated with insulin within 3 months of screening.
Location and Contact Information
Finland
Research Site, Helsinki, Finland; Recruiting
Netherlands
Research Site, Amsterdam, Netherlands; Recruiting
Sweden
Research Site, Goteborg, Sweden; Recruiting
More Information
Record last reviewed: March 2005
Last Updated: March 3, 2005
Record first received: November 24, 2004
ClinicalTrials.gov Identifier: NCT00097500
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Insulin glargine (Drug Digest)
- Lantus (Drug Digest)
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