Diabetes Mellitus Type 2 Clinical Trial
Official title:
A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.
Status | Completed |
Enrollment | 291 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - adult patients 18-75 years of age; - type 2 diabetes diagnosed >=1 month before screening; - no previous treatment, or previous treatment with no more than 2 oral medications. Exclusion Criteria: - type 1 diabetes; - type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening; - patients who are pregnant, breastfeeding or not using a reliable contraceptive method. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Bulgaria, Costa Rica, Estonia, Latvia, Lithuania, Mexico, Puerto Rico, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute change from baseline in HbAlc\n\n | Week 12 | No | |
Secondary | Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate | Week 12 | No | |
Secondary | AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n | Throughout study | No |
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