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Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM

NCT00820573 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-12-13

Study results available
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Summary

In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after 6 weeks of treatment:

Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on hepatic glucose production (HGP).

Hypothesis: After 6 weeks of treatment, the co-administration of sitagliptin and metformin provides greater reduction in hepatic glucose production (HGP) compared to placebo.

Conditions

Interventions

DRUG

Sitagliptin

tablet, 100 mg/day, 6 weeks

DRUG

Metformin

tablet, 1000 mg/ bid, 6 weeks

DRUG

Sitagliptin + Metformin

tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks

DRUG

Placebo

Placebo 6 weeks

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Eugenio Cersosimo, MD · University of TX Health Science Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00820573 on ClinicalTrials.gov