Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

Browse trials for

• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Keywords

• Type 2 Diabetes Mellitus

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 701 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Sitagliptin 100 mg

  The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

  Drug: Sitagliptin (MK0431) · Drug: Metformin · Drug: Pioglitazone

• Placebo comparator
  Placebo / Glipizide 5 mg

  The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.

  Drug: Placebo/Glipizide 5 mg · Drug: Metformin · Drug: Pioglitazone

Interventions

• DrugSitagliptin (MK0431)

  Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104

  Also known as: MK0431, sitagliptin phosphate, Januvia

• DrugPlacebo/Glipizide 5 mg

  Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)

• DrugMetformin

  Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)

• DrugPioglitazone

  Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)

  Also known as: ACTOS

Primary outcomes

1. Change From Baseline in Hemoglobin A1C (A1C) at Week 24

   A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

   Time frame: Baseline and Week 24

Secondary outcomes

1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

   Change from baseline at Week 24 is defined as FPG at Week 24 minus FPG at Week 0.

   Time frame: Baseline and Week 24

2. Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24

   Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.

   Time frame: Baseline and Week 24

Baseline characteristics

Publications

• Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006 Dec;29(12):2638-43. doi: 10.2337/dc06-0706. PubMed 17130197 ↗
• Xu L, Man CD, Charbonnel B, Meninger G, Davies MJ, Williams-Herman D, Cobelli C, Stein PP. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on beta-cell function in patients with type 2 diabetes: a model-based approach. Diabetes Obes Metab. 2008 Dec;10(12):1212-20. doi: 10.1111/j.1463-1326.2008.00887.x. Epub 2008 May 12. PubMed 18476982 ↗