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

May 4, 2017 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

870

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Glucophage
Active Comparator: Sulfonylurea Therapy
Usual sulfonylurea therapy with or without metformin
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 Names:
  • Glucophage
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 Names:
  • Amaryl (glimepiride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 30 days (Day 1 through last day of Ramadan)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days (Day 1 through last day of Ramadan)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2010

Primary Completion (Actual)

September 21, 2011

Study Completion (Actual)

September 21, 2011

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-262
  • CTRI/2011/06/001838 (Registry Identifier: CTRI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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