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Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Saira Burney, Services Hospital, Lahore
ClinicalTrials.gov Identifier:
NCT01624116
First received: March 19, 2012
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes, Type 2
 Drug: Acarbose
Other: Diet and lifestyle
Drug: Metformin
Drug: Metformin/ Glimepride
Drug: Metformin/Sitagliptin

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Services Hospital, Lahore:

Primary Outcome Measures:
  • Change in body weight and fructosamine levels during Ramadan fasting. [ Time Frame: 28 days (Average duration of Ramadan fasting) ] [ Designated as safety issue: No ]
    Change in body weight and fructosamine levels from baseline to end of Ramadan.


Secondary Outcome Measures:
  • Change in fasting lipid profile from baseline to end of Ramadan. [ Time Frame: 28 days(average duration of Ramadan) ] [ Designated as safety issue: No ]
    Change in fasting lipid profile from baseline to end of Ramadan.

  • Change in ghrelin levels from baseline to end of Ramadan. [ Time Frame: 28days (average duration of Ramadan) ] [ Designated as safety issue: No ]
    Change in ghrelin levels from baseline to end of Ramadan.

  • Change in renal profile from baseline to end of Ramadan [ Time Frame: 28 days(average duration of Ramadan) ] [ Designated as safety issue: No ]
    Change in renal profile from baseline to end of Ramadan.


Enrollment: 161
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diet and lifestyle measures alone.
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
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Name: *Tab.Glucobay 50mg (Bayer).
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Active Comparator: Metformin monotherapy
Type 2 diabetics on biguanide treatment.
 Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Name: *Tab.Glucobay 50mg (Bayer).
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
Other Name: Tablets Glucophage (Merck)
Active Comparator: Metformin + Sulphonylurea.
Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
 Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Name: *Tab.Glucobay 50mg (Bayer).
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Drug: Metformin/ Glimepride
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
Other Name: Tablet Getformin 1/500 (Getz Pharma)
Active Comparator: Metformin + Sitagliptin
Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
 Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Name: *Tab.Glucobay 50mg (Bayer).
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Drug: Metformin/Sitagliptin
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
Other Name: Tab.TreviaMet 50/500 (Getz Pharma)

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624116

Locations
Pakistan
Endocrinology Unit & Diabetes Management Centre, Services Hospital.
Lahore, Pakistan
Sponsors and Collaborators
Services Hospital, Lahore
Investigators
Principal Investigator: Dr Khadija Irfan, MBBS,FCPS Services Hospital.
  More Information

No publications provided

Responsible Party: Dr Saira Burney, Senior Registrar, Endocrinology Unit & Diabetes Management Centre, Services Institute of Medical Sciences,Lahore,Pakistan., Services Hospital, Lahore
ClinicalTrials.gov Identifier: NCT01624116     History of Changes
Other Study ID Numbers: RT2011
Study First Received: March 19, 2012
Last Updated: June 19, 2012
Health Authority: Pakistan: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Hypoglycemic Agents
Metformin
 Acarbose
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013