Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Overview[ - collapse ][ - ]

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.
ConditionDiabetes, Type 2
InterventionDrug: Acarbose
Other: Diet and lifestyle
Drug: Metformin
Drug: Metformin/ Glimepride
Drug: Metformin/Sitagliptin
PhaseN/A
SponsorServices Hospital, Lahore
Responsible PartyServices Hospital, Lahore
ClinicalTrials.gov IdentifierNCT01624116
First ReceivedMarch 19, 2012
Last UpdatedJune 19, 2012
Last verifiedJune 2012

Tracking Information[ + expand ][ + ]

First Received DateMarch 19, 2012
Last Updated DateJune 19, 2012
Start DateAugust 2011
Estimated Primary Completion DateSeptember 2011
Current Primary Outcome MeasuresChange 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.
Current 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.

Descriptive Information[ + expand ][ + ]

Brief TitleComparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes
Official TitleA 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
Brief 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.
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes, Type 2
InterventionDrug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
*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 Names:
Tablets Glucophage (Merck)Drug: Metformin/ Glimepride
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
Other Names:
Tablet Getformin 1/500 (Getz Pharma)Drug: Metformin/Sitagliptin
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
Other Names:
Tab.TreviaMet 50/500 (Getz Pharma)
Study Arm (s)
  • 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
  • Active Comparator: Metformin monotherapy
    Type 2 diabetics on biguanide treatment.
  • Active Comparator: Metformin + Sulphonylurea.
    Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
  • Active Comparator: Metformin + Sitagliptin
    Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment161
Estimated Completion DateSeptember 2011
Estimated Primary Completion DateSeptember 2011
Eligibility 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.
GenderBoth
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesPakistan

Administrative Information[ + expand ][ + ]

NCT Number NCT01624116
Other Study ID NumbersRT2011
Has Data Monitoring CommitteeNo
Information Provided ByServices Hospital, Lahore
Study SponsorServices Hospital, Lahore
CollaboratorsNot Provided
Investigators Principal Investigator: Dr Khadija Irfan, MBBS,FCPS Services Hospital.
Verification DateJune 2012

Locations[ + expand ][ + ]

Endocrinology Unit & Diabetes Management Centre, Services Hospital.
Lahore, Pakistan