Trial | NCT00525330  Report issue

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    krp-104 sitagliptin ...

  • Study Participants

    213
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.
Study Started
Sep 30
2007
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2008
Last Update
Aug 22
2013
Estimate

Drug KRP-104 QD Drug: Placebo Drug: Metformin

KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal

Drug Placebo Drug: Metformin

Two tablets 15 to 30 minutes before each meal, morning and evening.

Drug KRP-104 BID Drug: Placebo Drug: Metformin

KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening.

KRP-104 120 mg QD Experimental

KRP-104 60 mg BID Experimental

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

Age 18 to 70 years, inclusive;
Males and females of non-childbearing potential;
Diagnosis of type 2 diabetes mellitus according; and
On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry

Exclusion Criteria:

History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
History or presence of alcoholism or drug abuse
Typical consumption of ≥10 drinks of alcohol weekly;

Presence of any of the following conditions:

Significant renal impairment (glomerular filtration rate <60 mL/min [to be calculated by the central laboratory]);
Diabetic retinopathy;
Diabetic gastroparesis;
Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
Uncontrolled high blood pressure;
History or evidence of cardiovascular or pulmonary disease
Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals
No Results Posted