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30-Week Extension to an Initial Combination Study (24 weeks in duration) of Sitagliptin With Pioglitazone (0431-064)

ClinicalTrials.gov Identifier: NCT01028391 (view full study on clinicaltrials.gov)
Condition:  Type 2 Diabetes Mellitus
Status:  Completed


Official Title: A 30-Week Extension to: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus

A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.

Study Type:
Interventional
Study Phase:
Phase 3
Enrollment:
317
Study Start Date:
September 2007
Study Completion Date:
January 2009
Primary Completion Date:
January 2009
Ages Eligible for Study:
18 years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No


CRITERIA

Inclusion Criteria:

  • Patients must complete the double-blind base study (MK-0431-064-00)(NCT00397631) and have at least 75% compliance with study medication during the base study treatment period.
  • Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods

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