Study to Assess Safety & Efficacy of Sitagliptin as Initial Monotherapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants (MK-0431-083 AM1)
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Purpose
The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Type 2 Diabetes |
Drug: Sitagliptin Drug: Metformin Drug: Placebo to sitagliptin Drug: Placebo to metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicenter, Double-Blind, Randomized, Placebo and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control |
- Change from baseline in A1C [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Number of participants with adverse events [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 360 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sitagliptin
Sitagliptin 100 mg oral tablet once a day and placebo to metformin oral tablet twice a day for 54 weeks
|
Drug: Sitagliptin
100 mg oral tablet of sitagliptin prior to the morning meal
Other Name: Januvia
Drug: Placebo to sitagliptin
Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the metformin arm and the 2 arms with placebo for phase A will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the metformin arm and the placebo phase A/ metformin phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the sitagliptin arm and the 2 arms with placebo for phase A will receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal Phase B: Participants in the sitagliptin arm and the placebo phase A/ sitagliptin phase B arm will continue to receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal |
|
Active Comparator: Metformin
Metformin (500 mg) oral tablets, twice a day and placebo to sitagliptin (100 mg), oral tablet once a day for 54 weeks
|
Drug: Metformin
Metformin(500 mg) oral tablets prior to both the morning and evening meals
Other Name: Glucophage
Drug: Placebo to sitagliptin
Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the metformin arm and the 2 arms with placebo for phase A will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the metformin arm and the placebo phase A/ metformin phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the sitagliptin arm and the 2 arms with placebo for phase A will receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal Phase B: Participants in the sitagliptin arm and the placebo phase A/ sitagliptin phase B arm will continue to receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal |
|
Experimental: Placebo phase A / Metformin phase B
Placebo to sitagliptin oral tablet once a day and placebo to metformin oral tablets twice a day for 16 weeks (Phase A), followed by metformin oral tablets twice a day and placebo to sitagliptin oral tablet once a day for 38 weeks (Phase B).
|
Drug: Metformin
Metformin(500 mg) oral tablets prior to both the morning and evening meals
Other Name: Glucophage
Drug: Placebo to sitagliptin
Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the metformin arm and the 2 arms with placebo for phase A will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the metformin arm and the placebo phase A/ metformin phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the sitagliptin arm and the 2 arms with placebo for phase A will receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal Phase B: Participants in the sitagliptin arm and the placebo phase A/ sitagliptin phase B arm will continue to receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal |
|
Experimental: Placebo phase A / Sitagliptin phase B
Placebo to sitagliptin oral tablet once a day and placebo to metformin oral tablets twice a day for 16 weeks (Phase A), followed by sitagliptin oral tablet once a day and placebo to metformin oral tablets twice a day for 38 weeks (Phase B).
|
Drug: Sitagliptin
100 mg oral tablet of sitagliptin prior to the morning meal
Other Name: Januvia
Drug: Placebo to sitagliptin
Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the metformin arm and the 2 arms with placebo for phase A will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the metformin arm and the placebo phase A/ metformin phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Placebo run-in: For 1 week all participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal and 2 oral tablets of placebo to metformin prior to both the morning and evening meals. After randomization: Participants randomized to the sitagliptin arm and the 2 arms with placebo for phase A will receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal Phase B: Participants in the sitagliptin arm and the placebo phase A/ sitagliptin phase B arm will continue to receive 2 oral tablets of placebo to metformin prior to both the morning and evening meal |
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 Diabetes Mellitus (T2DM)
- Has not received treatment with an oral antihyperglycemic agent (AHA) for ≥12 weeks prior to the Screening Visit/Visit 1, or with insulin for at least 6 months prior to the Screening Visit/Visit 1.
- An A1C of ≥7.0% and ≤10.0%.
Exclusion Criteria:
- Diabetes for >1 year.
- History of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD (Glutamic Acid Decarboxylase) or (Islet cell autoantigen)ICA-512.
- 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 antihyperglycemic therapy.
- Previously taken a DPP-4 (Dipeptidyl peptidase-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or (Glucagon-like peptide-1) GLP-1 receptor agonist (such as exenatide or liraglutide).
- Hypersensitivity or contraindication (according to the product circular in the country of the investigational site) to metformin.
- On or likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
- Undergone a surgical procedure within the prior 4 weeks or has major surgery planned during the study.
- History of congenital heart disease or cardiovascular disease other than hypertension.
- Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease.
- Active nephropathy (i.e., nephrotic syndrome or glomerulonephritis).
- Chronic myopathy, mitochondrial disorder, or a progressive neurological or neuromuscular disorder (e.g., polymyositis, or multiple sclerosis).
- Human immunodeficiency virus (HIV) as assessed by medical history.
- Clinically significant hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndrome).
- Under treatment for hyperthyroidism.
- Exhibits abnormal growth patterns or is being treated with growth hormone.
- History of malignancy or clinically important hematologic disorder.
- History of idiopathic acute pancreatitis or chronic pancreatitis.
- Known history of recreational or illicit drug use, or of alcohol abuse or dependence (within the past year).
- Donated blood products or has had phlebotomy of >10% of estimated total blood volume within 8 weeks of signing informed consent, or intends to donate blood products or receive blood products within the projected duration of the study.
- Pregnant, has a positive urine pregnancy test at Screening Visit/Visit 1, is expecting to conceive within the projected duration of the study, or is breast-feeding.
- Exclusionary laboratory values.
- History of idiopathic acute pancreatitis or chronic pancreatitis.
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 |
Show 29 Study Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01485614 History of Changes |
| Other Study ID Numbers: | 0431-083 |
| Study First Received: | December 1, 2011 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013