Conditions: Diabetes Mellitus, Type 2
Keywords: NIDDM
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 375
Healthy volunteers: no

Brief summary:
This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Detailed description:
A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Arms:
arm 1: Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 milligram (mg) once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants. arm 2: Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants. arm 3: Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants. arm 4: Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants. arm 5: Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants. arm 6: Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.

Interventions: intervention 1: Placebo intervention 2: DEN 2.5 mg intervention 3: DEN 7.5 mg intervention 4: DEN 15 mg intervention 5: DEN 30 mg intervention 6: DEN 45 mg
Intervention descriptions: intervention 1: Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 2: DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 3: DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 4: DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 5: DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 6: DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Protocol document: