Sitagliptin vs sulphonylurea based treatments in Muslim patients with Type 2 diabetes during Ramadan - Januvia vs sulphonylurea in Ramadan study 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002607-12-GB

Enrollment

200

Registered

2008-07-16

Start date

2008-08-08

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muslim patients with type 2 diabets fasting during Ramadan

Interventions

Trade Name: JANUVIA Product Name: sitagliptin Pharmaceutical Form: Tablet INN or Proposed INN: Sitagliptin Other descriptive name: JANUVIA

MK0431 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Multiple Trade names Product Name: Sulphonylurea Pharmaceutical Form: Tablet INN or Propose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Muslim men and women with Type 2 diabetes. 2. Age 18-78 years 3. Intending to fast during the month of Ramadan 4. On oral antihyperglycemic agents (sulphonylurea based/combination therapy) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patient with hypersensitivity or contraindication to sitagliptin treatment 2. Patient with hypersensitivity or contraindication to SU treatment 3. Patient with CKD (creatinine clearance <50 ml/min) 4. Patients who have participated in another intervention study in the last 2 months 5. Patients who do not give informed consent 6. Pregnant or breast feeding women. 7. Patients on insulin 8. Patients with severe liver disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To define metabolic alterations during Ramadan: Primary end point: Occurrence of hypoglycaemia (blood glucose < 3.3 mmol/l with or without symptoms) recorded by patients in a self-monitoring diary together with blood glucose values;Secondary Objective: Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c), triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C). A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.;Primary end point(s): The primary endpoints of the study will be the incidence of self reported hypoglycemia plus associated BM recording in a personal diary. It has been reported that the incidence of hypoglycemia in patients on sulphonylurea and combination treatment increases by 19.5% during Ramadan. In a head to head non-inferiority study using sitagliptin vs sulphonylurea addition to metformin, the incidence of hypoglycemia was 4.9% and 32% respectively. No data is available on the use of sitagliptin in diabetic patients during Ramadan. We hypothesise that sitagliptin addition to metformin or pioglitazone is better than current sulphonylurea based treatments during Ramadan. Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia and low incidence of wt gain over current sulphonylurea based treatments.	—

Measure

Time frame

Main Objective: To define metabolic alterations during Ramadan: Primary end point: Occurrence of hypoglycaemia (blood glucose < 3.3 mmol/l with or without symptoms) recorded by patients in a self-monitoring diary together with blood glucose values;Secondary Objective: Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c), triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C). A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.;Primary end point(s): The primary endpoints of the study will be the incidence of self reported hypoglycemia plus associated BM recording in a personal diary. It has been reported that the incidence of hypoglycemia in patients on sulphonylurea and combination treatment increases by 19.5% during Ramadan. In a head to head non-inferiority study using sitagliptin vs sulphonylurea addition to metformin, the incidence of hypoglycemia was 4.9% and 32% respectively. No data is available on the use of sitagliptin in diabetic patients during Ramadan. We hypothesise that sitagliptin addition to metformin or pioglitazone is better than current sulphonylurea based treatments during Ramadan. Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia and low incidence of wt gain over current sulphonylurea based treatments.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026