NCT01624116

Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

A Comparison of Four Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetic Patients and the Effect of Add-On Acarbose on Glycaemic Excursions During Ramadan Fasting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Services Hospital, Lahore · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.

Detailed description

Study Objectives: * To compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in Ramadan between four treatment arms: * diet and lifestyle measures alone. * metformin monotherapy. * combination therapy with metformin + sulfonylurea. * combination therapy with metformin + sitagliptin. * To compare the 24 hour CGMS profile during Ramadan fasting in type 2 diabetic patients before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.

Conditions

• Diabetes, Type 2

Interventions

Type	Name	Description
DRUG	Acarbose	Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
OTHER	Diet and lifestyle	Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
DRUG	Metformin	Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose
DRUG	Metformin/ Glimepride	Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
DRUG	Metformin/Sitagliptin	Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2012-06-20
• Last updated: 2012-06-20

Locations

1 site across 1 country: Pakistan