A 66-WEEK EXTENSION TO: A PHASE IIB, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGE FINDING CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-3102 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCEMIC CONTRO

Not Applicable

• Registration Number: PER-062-11
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. COMPLETE THE DOUBLE-BLIND BASE STUDY (WITH OR WITHOUT INIATIATION OF GLYCEMIC RESCUE MEDICATION WITH OPEN-LABEL METFORMIN).
2. HAVE ≥ 75% COMPLIANCE WITH DOUBLE-BLIND STUDY MEDICATION DURING THE BASE STUDY DOUBLE-BLIND TREATMENT PERIOD.
3. UNDERSTAND THE EXTENSION STUDY PROCEDURES AND AGREE TO PARTICIPATE IN THE EXTENSION BY GIVING WRITTEN INFORMED CONSENT.
4. WOMEN OF CHILDBEARING POTENTIAL MUST CONTINUE TO COMPLY WITH THE PROTOCOL- SPECIFIED CONTRACEPTIVE METHODS AS PREVIOUSLY OUTLINED IN THE BASE STUDY.

Exclusion Criteria

1. PATIENT HAS A HISTORY OF INTOLERANCE OR ANY CONTRAINDICATION FOR THE USE OF PIOGLITAZONE OR METFORMIN DESCRIBED IN THE PACKAGE INSERT FROM THE COUNTRY OF THE INVESTIGATIONAL SITE.
2. PATIENT MEETS ANY OF THE BASE STUDY CRITERIA FOR DISCONTINUATION FROM THE STUDY DRUG.
3. PATIENT HAS CONGESTIVE HEART FAILURE (NYHA 1-IV).
4. PATIENT REQUIRES OR IS LIKELY TO REQUIRE THERAPY WITH GEMFIBROZIL OR OTHER STRONG CYP2C8 INHIBITORS.
5. PATIENT HAS EXCLUSIONARY LABORATORY VALUES BASED ON THE CENTRAL LAB RESULTS FROM THE LAST VISIT PRIO TO THIS AMENDMENT BEING APPROVED (OR FROM VISIT 7 FOR THOSE PATIENTS NOT ALREADY ENTERED INTO THE EXTENSION) AS LISTED IN TABLE THE 2-1 BELOW.
6. PATIENT HAS BLADDER CANCER OR HAS A HISTORY OF BLADDER CANCER.

Study & Design

• Study Type: Interventional
• Study Design: Not specified