A Double-Blind, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet™ Compared to Metformin

Meir Medical Center1 site in 1 country1,000 target enrollmentJune 2008

ConditionsDiabetes Type 2

InterventionsMetformin 1500 mg daily Metformin + Janufer (Janumet)

DrugsMetformin 1500 mg daily Metformin + Janufer (Janumet)

Overview

Phase: Phase 3
Intervention: Metformin 1500 mg daily
Conditions: Diabetes Type 2
Sponsor: Meir Medical Center
Enrollment: 1000
Locations: 1
Primary Endpoint: The efficacy and safety of community based study in diabetic patients, comparing Metformin to Metformin + Janufer.
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of this drug and additional drug (Janufer), In the community setting.

Detailed Description

This is a randomized, double-blind, active-comparator (metformin) controlled study in drug-naïve patients with T2DM who have an HbA1c ≥ 7.5%. The duration of the study is 55 weeks, which will include a 1-week screening period (Visit 1 to Visit 2) and a 54 week double-blind, active treatment period. At Visit 2/Day 1 patients who meet all enrollment criteria will be randomized in a 1:1 ratio to one of two active treatment groups: 1. JANUMET™ (fixed-dose combination sitagliptin/metformin) or 2. metformin. The starting fixed-dose combination of sitagliptin/metformin will be 50/500 mg administered twice-daily and then up-titrated to a dose of 50/1000 mg b.i.d. over 4 weeks. The starting dose of metformin will be 500 mg twice-daily and then up-titrated to a dose of 1000 mg b.i.d. over 4 weeks. Patients who can not tolerate JANUMET™ at a dose of at least 50/500 mg b.i.d. or metformin at a dose of at least 500 mg b.i.d. 6 weeks after randomization and throughout the study will be discontinued. During the double-blind treatment period patients will remain on the study medication, but investigators are allowed to add other antihyperglycemic agents to improve glycemic control as necessary. The investigator can schedule additional visits to initiate additional antihyperglycemic agents or monitor glycemic control at any time during the study period. There will be no fixed visit schedule, but 7 clinical visits are recommended. It is also recommended to perform the first visit on active treatment 6 weeks after randomization and after this visit to schedule visits every 3 months. All clinical and lab data can be obtained using the "Clalit health care information system".

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

December 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meir Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All laboratory measurements are to be performed after an overnight fast ≥ 10 hours in duration. Patients with laboratory screening values/findings not meeting protocol inclusion criteria may, at the discretion of the investigator, have one repeat determination performed. If the repeat value satisfies the criterion they may continue in the screening process. Only the laboratory test not meeting inclusion should be repeated (not the entire panel).

Exclusion Criteria

•Glucose Metabolism and Therapy Criteria
•Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. Patients Requiring Specific Treatments
•Patient has symptomatic hyperglycemia requiring immediate initiation of insulin therapy.
•Patient has a history of intolerance or hypersensitivity to metformin or sitagliptin or has any contraindication to use metformin.
•Concomitant Disease of Organs and Systems
•Patient has a medical history of active liver disease (excluding hepatic steatosis).
•Patient has severe active peripheral vascular disease (e.g., manifested by claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require intervention such as with bypass or angioplasty).
•Patient has unstable or acute congestive heart failure.
•Patient has a history of malignancy without documentation of remission/cure. Other Criteria
•Patient is pregnant, has a positive urine pregnancy test at Visit 1, is expecting to conceive within the projected duration of the study, or is breast feeding.