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A Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise - ND

A Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001771-11-IT
Enrollment
208
Registered
2007-07-04
Start date
2007-07-02
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: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent

Interventions

Trade Name: Sitagliptin Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of adminis

Sponsors

MERCK SHARP DOHME
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient has type 2 diabetes mellitus T2DM diagnosed within the past 5 years. b. Patient is 8805;30 and 8804;65 years of age on the day of signing informed consent. c. Patient has a BMI that is 8805;23 and 8804;40 kg/m2. 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. b. Patient is assessed by the investigator as possibly having type I diabetes confirmed with a C-peptide 8804;0.7 ng/mL 0.23 nmol/L . Note Only patients assessed by the investigator as possibly having type I diabetes should have C-peptide measured at Visit 1. c. Patient has been taking sitagliptin, vildagliptin or exenatide Byetta within the prior 12 weeks. d. Patient has been taking a PPAR 947; agent i.e. a TZD, pioglitazone or rosiglitazone within the prior 12 weeks. e. Patient has required insulin therapy within the past 12 weeks.

Design outcomes

Primary

MeasureTime frame
Main Objective: After 12 weeks, to assess the effect of treatment with sitagliptin compared with placebo on post-prandial glucagon AUC during a meal tolerance test MTT and beta cell function markers HOMA index . To assess the safety and tolerability of sitagliptin in combination with pioglitazone.;Secondary Objective: After 12 weeks, to assess the effect of co-administration of sitagliptin and pioglitazone compared with placebo on total glucose AUC during the MTT.After 12 weeks, to assess the effect of treatment with sitagliptin compared with pioglitazone on 934;s.;Primary end point(s): glucose AUC—

Countries

Italy

Outcome results

None listed

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