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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340768
• Other study ID #: 0431-262
• Secondary ID: CTRI/2011/06/001
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: February 4, 2016
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
One 100 mg tablet taken orally once daily
• Sulfonylurea
Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.
• 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.

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	Percentage of Participants With at Least One Symptomatic Hypoglycemic Event	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)	Yes
Secondary	Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	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)	Yes