Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGKRP-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
DRUGPlacebo Drug: Metformin
Two tablets 15 to 30 minutes before each meal, morning and evening.
DRUGKRP-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.
Sponsors
Kyorin Pharmaceutical Co.,Ltd
ActivX Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 12-weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone; | 12-weeks | — |
| To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG | 12 weeks | — |
| 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) | 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. |
| To assess the safety and tolerability of KRP-104; | Daily for 12 weeks to 2 weeks post-treatment | — |
Countries
United States
Outcome results
None listed