Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Diabetes, Type 2 Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes, Type 2

• NCT number: NCT01624116
• Study type: Interventional
• Source: Services Hospital, Lahore
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Completion date: September 2011