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A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001392-37-AT
Enrollment
200
Registered
2006-06-28
Start date
2006-07-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus MedDRA version: 7.0 Level: LLT Classification code 10045242

Interventions

Product Name: sitagliptin Product Code: MK-0431 Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo:

Sponsors

Merck Sharp & Dohme GesmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. At Visit 4, patient has an HbA1c = 8 % and = 11%. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a. Visit 4 FPG concentration is = 15% lower than the Visit 3 FPG concentration

Design outcomes

Primary

MeasureTime frame
Main Objective: Main objective : After 18 weeks, to assess the effect of the addition of treatment with sitagliptin compared to placebo on HbAic.;Secondary Objective: 1. After 18 weeks, to assess the effect of the addition of treatment with sitagliptin compared to placebo on the post-meal glucose [e.g., 2-hour post prandial glucose (2-hour PPG), glucose AUC] after a meal tolerance test. 2. After 18 weeks, to assess the effect of the addition of treatment with sitagliptin compared to placebo on fasting plasma glucose (FPG). 3. After 30 weeks, to assess the effect of the addition of treatment with sitagliptin compared to placebo on HbA1c. ;Primary end point(s): HbA1c after 18 weeks—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026