Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

Type 2 Diabetes Mellitus (T2DM) 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: NCT01131182
• Other study ID #: 0431-263
• Secondary ID: 2010_538
• Status: Completed
• Phase: Phase 4
• Start date: June 13, 2010
• Est. completion date: November 4, 2010

Study information

• Verified date: August 2022
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

Description:

This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1147
• Est. completion date: November 4, 2010
• Est. primary completion date: November 4, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Muslim men and women with type 2 diabetes

• Participants who intend to fast during the month of Ramadan

• Participants who have been on a stable dose of sulfonylurea for at least three months

Exclusion Criteria:

• Participants with type 1 diabetes mellitus

• Pregnant or breast feeding women

• Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment

• Participants on insulin

• Participants on any class of oral diabetic therapy other than sulfonylurea or metformin

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• Sitagliptin phosphate
Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
• Comparator: Sulfonylurea
Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
• Metformin
Participants could continue pre-study metformin as concomitant therapy during the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

References & Publications (1)

Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, Al Tayeb K, Mahfouz AS, Al Elq A, Radican L, Ozesen C, Katzeff HL, Musser BJ, Suryawanshi S, Girman CJ, Davies MJ, Engel SS; 2010 Ramadan Study Group. The incidence of hypoglycaemia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With at Least One Symptomatic Hypoglycemic Event	Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.	30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
Secondary	Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.	30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)