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Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

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ClinicalTrials.gov Identifier: NCT01340768
Recruitment Status : Completed
First Posted : April 25, 2011
Results First Posted : October 8, 2012
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin Drug: Sulfonylurea Drug: Metformin Phase 3

Detailed Description:
This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting
Actual Study Start Date : June 22, 2010
Actual Primary Completion Date : September 21, 2011
Actual Study Completion Date : September 21, 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sitagliptin
Sitagliptin 100mg taken orally once daily with or without metformin
 Drug: Sitagliptin
One 100 mg tablet taken orally once daily
Other Name: Sitagliptin phosphate, MK-0431, JANUVIA®

Drug: Metformin
Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.
Other Name: Glucophage
Active Comparator: Sulfonylurea Therapy
Usual sulfonylurea therapy with or without metformin
 Drug: Sulfonylurea
Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.
Other Name: Amaryl (glimepiride)

Drug: Metformin
Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.
Other Name: Glucophage


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With at Least One Symptomatic Hypoglycemic Event [ Time Frame: Up to 30 days (Day 1 through last day of Ramadan) ]
    Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).


Secondary Outcome Measures :
  1. Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event [ Time Frame: Up to 30 days (Day 1 through last day of Ramadan) ]
    Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Muslim, with type 2 diabetes mellitus
  • Intends to fast during the month of Ramadan
  • Hemoglobin A1c (HbA1c) ≤10% at screening
  • On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Pregnant or breast feeding or with gestational diabetes
  • Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
  • Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
  • History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
  • Any use of insulin (prior to or during Ramadan)
  • Use of any class of oral antidiabetic therapy other than an SU or metformin
  • Current participation in another interventional study
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT01340768    
Other Study ID Numbers: 0431-262
CTRI/2011/06/001838 ( Registry Identifier: CTRI )
First Posted: April 25, 2011    Key Record Dates
Results First Posted: October 8, 2012
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php
Keywords provided by Merck Sharp & Dohme LLC:
Glucose metabolism disorders Metabolic diseases Peptidase inhibitors
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors