Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes, Type 2

Intervention / Treatment
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* Drug: Acarbose
* Other: Diet and lifestyle
* Drug: Metformin
* Drug: Metformin/ Glimepride
* Drug: Metformin/Sitagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HbA1c 6.5-9.5%. Type 2 diabetics on two or less oral hypoglycaemic agents. Exclusion Criteria: Any contraindications either to fasting or to any of the trial medication. Pregnancy. Serum creatinine > 1.4 mg/dl. Serum ALT > twice upper limit normal. History of pancreatitis, serum amylase > twice upper limit normal. History of intolerance to acarbose.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet and lifestyle measures alone.<br>Type 2 diabetic subjects on lifestyle counselling as part of diabetes treatment would continue as such during Ramadan. They would receive acarbose on one day to be followed by CGMS for a 24 hour period | Drug: Acarbose<br>* Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.<br>* Other names: *Tab.Glucobay 50mg (Bayer).;Other: Diet and lifestyle<br>* Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day<br>|
| Active Comparator: Metformin monotherapy<br>Type 2 diabetics on biguanide treatment. | Drug: Acarbose<br>* Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.<br>* Other names: *Tab.Glucobay 50mg (Bayer).;Other: Diet and lifestyle<br>* Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day<br>Drug: Metformin<br>* Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose<br>* Other names: Tablets Glucophage (Merck);|
| Active Comparator: Metformin + Sulphonylurea.<br>Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride. | Drug: Acarbose<br>* Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.<br>* Other names: *Tab.Glucobay 50mg (Bayer).;Other: Diet and lifestyle<br>* Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day<br>Drug: Metformin/ Glimepride<br>* Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD<br>* Other names: Tablet Getformin 1/500 (Getz Pharma);|
| Active Comparator: Metformin + Sitagliptin<br>Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin. | Drug: Acarbose<br>* Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.<br>* Other names: *Tab.Glucobay 50mg (Bayer).;Other: Diet and lifestyle<br>* Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day<br>Drug: Metformin/Sitagliptin<br>* Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.<br>* Other names: Tab.TreviaMet 50/500 (Getz Pharma);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight and fructosamine levels during Ramadan fasting. | Change in body weight and fructosamine levels from baseline to end of Ramadan. | 28 days (Average duration of Ramadan fasting) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting lipid profile from baseline to end of Ramadan. | Change in fasting lipid profile from baseline to end of Ramadan. | 28 days(average duration of Ramadan) | 
| Change in ghrelin levels from baseline to end of Ramadan. | Change in ghrelin levels from baseline to end of Ramadan. | 28days (average duration of Ramadan) | 
| Change in renal profile from baseline to end of Ramadan | Change in renal profile from baseline to end of Ramadan. | 28 days(average duration of Ramadan) |