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Completed

NCT Number: NCT00525330

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRP-104 QD Drug: Placebo Drug: Metformin

Drug

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

Placebo Drug: Metformin

Drug

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

KRP-104 BID Drug: Placebo Drug: Metformin

Drug

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.

Primary outcomes

  1. The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone.

    Time frame: 12-weeks

Secondary outcomes

  1. To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;

    Time frame: 12-weeks

  2. To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG

    Time frame: 12 weeks

  3. To assess the effects of KRP-104 on post-prandial glucose dynamics and insulin sensitivity (homeostasis model index [HOMA-β]) in the setting of a Meal Tolerance Test(MTT)

    Time frame: 12 weeks

    Changes from pre-prandial to 2-hour post-prandial glucose, active GLP-1, insulin summarized by treatment group from Week 0 to Week 5 and Week 12. Percent change in 2-hour post-prandial glucose summarized by treatment group from Week 0 to Week 5 and Week 12.

  4. To assess the safety and tolerability of KRP-104;

    Time frame: Daily for 12 weeks to 2 weeks post-treatment

Sponsors and collaborators

Lead sponsor

ActivX Biosciences, Inc.

Industry

Collaborators

  • Kyorin Pharmaceutical Co.,Ltd

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 5, 2007
Registry last updated
Aug 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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