A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472367
• Other study ID #: 0431A-170
• Secondary ID: CTRI/2012/09/003
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2011
• Est. completion date: September 17, 2019

Study information

• Verified date: September 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy (alone or in combination with insulin). The primary hypothesis is that the addition of sitagliptin reduces A1C more than the addition of placebo after 20 weeks of treatment. Participants who complete the 20-week base period of the study may choose to participate in the extension period of the study and continue on or off treatment assigned during the base period for an additional 34 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Has Type 2 Diabetes Mellitus (T2DM)

• Is on metformin monotherapy (=1500 mg/day) for =12 weeks with A1C =6.5% and =10.0% OR is on stable doses of metformin (=1500 mg/day) and insulin for =12 weeks with an A1C =7.0% and =10%. NOTE: Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated.

• Between 10 and 17 years of age on day of signing informed consent with randomization to occur prior to 18th birthday.

• Participant and a family member or adult closely involved in the daily activities will participate in the participant's treatment and study protocol (i.e., available for telephone calls, study visits and administration of study medication as needed).

Exclusion Criteria:

• Known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when participant was diagnosed with diabetes).

• Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.

• Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent.

• Participant has previously taken a dipeptidyl peptidase-IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or glucagon-like peptide-1 (GLP-1) receptor agonist (such as exenatide or liraglutide).

• Exhibits abnormal growth patterns or is being treated with growth hormone.

• History of idiopathic acute pancreatitis or chronic pancreatitis.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin
Metformin oral tablets twice daily. Participants on a metformin daily dose of 1000, 1250, or 1275 mg at screening will be switched to a metformin daily dose of 1000 mg (500 mg twice a day); 1500, 1700, or 1750 mg will be switched to a metformin daily dose of 1700 mg (850 mg twice a day); 2000 mg or more will be switched to a metformin daily dose of 2000 mg (1000 mg twice a day).
• Sitagliptin + Metformin FDC
Sitagliptin + metformin FDC oral tablet 50/500, 50/850, or 50/1000 mg dosed twice daily.
• Placebo to Metformin
Matching placebo to metformin administered twice daily.
• Placebo to Sitagliptin + Metformin FDC
Matching placebo to sitagliptin + metformin FDC oral tablet administered twice daily.

Biological:
• Insulin
Participants who enter the study on background insulin will continue on the same dose and formulation of insulin throughout the study. If rescue therapy is necessary, participants who are not on background insulin will intiate insulin and those that entered the study on insulin will uptitrate their background insulin dose.
• Insulin glargine
Participants who are not on background insulin therapy during the base study may initiate insulin glargine during the extension period if their fasting fingerstick glucose is >130 mg/dL and their fasting state A1C is greater than 7.5%.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hemoglobin A1c (A1C) at Week 20		Baseline and Week 20
Primary	Number of participants with adverse events up to Week 20		Up to 20 weeks
Primary	Number of participants who discontinued study drug due to an adverse event up to Week 20		Up to 20 weeks
Primary	Number of participants with adverse events up to Week 54		Up to 54 weeks
Primary	Number of participants who discontinued study drug due to an adverse event up to Week 54		Up to 54 weeks
Secondary	Change from baseline in FPG at Week 20		Baseline and Week 20
Secondary	Percentage of participants with A1C goals (<7%; <6.5%) at Week 20		Week 20
Secondary	Percentage of participants who initiate glycemic rescue therapy by Week 20		Up to 20 weeks