WHO ICTRP trial

A 12-WEEK PROOF OF CONCEPT STUDY FOR PF-04991532 IN T2DM SUBJECTS.

EUCTR2011-000602-22-SK · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2011-000602-22-SK
Public title A 12-WEEK PROOF OF CONCEPT STUDY FOR PF-04991532 IN T2DM SUBJECTS.
Scientific title A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE DAILY PF-04991532 AND SITAGLIPTIN IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN
Primary sponsor Pfizer Inc
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Serbia;Hungary;Taiwan;Mexico;Slovakia;Korea, Democratic People's Republic of;Bulgaria;India
Conditions Type 2 Diabetes Mellitus MedDRA version: 13.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Nutritional and…
Interventions Product Name: Not Applicable Product Code: PF-04991532 Pharmaceutical Form: Tablet INN or Proposed INN: Not Applicable Current Sponsor code: PF-04991532 Other descriptive name: Not Applicable Concentration unit: mg milligram(s)…
Registration date May 26, 2011
Target size 240
Secondary IDs B2611002
Registry page clinicaltrialsregister.eu

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