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

ActivX Biosciences

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo Drug: Metformin; Drug: KRP-104 BID Drug: Placebo Drug: Metformin; Drug: KRP-104 QD Drug: Placebo Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00525330

0104-003

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;

2. History or presence of alcoholism or drug abuse

3. Typical consumption of ≥10 drinks of alcohol weekly;

4. 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;

5. Uncontrolled high blood pressure;

6. History or evidence of cardiovascular or pulmonary disease

7. Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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213 participants in 3 patient groups, including a placebo group

KRP-104 120 mg QD

Experimental group

Treatment:

Drug: KRP-104 QD Drug: Placebo Drug: Metformin

KRP-104 60 mg BID

Experimental group

Treatment:

Drug: KRP-104 BID Drug: Placebo Drug: Metformin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Drug: Metformin