Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Services Hospital, Lahore

Status: Completed

Conditions: Diabetes, Type 2

Treatments: Drug: Metformin/ Glimepride; Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin; Drug: Metformin/Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01624116

RT2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 4 patient groups

Diet and lifestyle measures alone.

Active Comparator group

Description:

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

Treatment:

Other: Diet and lifestyle

Drug: Acarbose

Metformin monotherapy

Active Comparator group

Description:

Type 2 diabetics on biguanide treatment.

Treatment:

Drug: Metformin

Other: Diet and lifestyle

Drug: Acarbose

Metformin + Sulphonylurea.

Active Comparator group

Description:

Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.

Treatment:

Other: Diet and lifestyle

Drug: Metformin/ Glimepride

Drug: Acarbose

Metformin + Sitagliptin

Active Comparator group

Description:

Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.

Treatment:

Drug: Metformin/Sitagliptin

Other: Diet and lifestyle

Drug: Acarbose