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Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes

Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes - Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024427
Enrollment
30
Registered
2016-10-16
Start date
2017-07-19
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Type 2 diabetes

Interventions

Dapagliflozin 5 mg per day for 12 weeks Sitagliptin 50 mg per day for 12 weeks Metformin 1000 mg per day for 12 weeks

Sponsors

Ogawa Red Cross Hospital
Lead Sponsor
Saitama Medical University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetic patients 2. HbA1c higher than 6.5% and lower than 11.0% 3. BMI higher than 18 and lower than 40 kg/m2 4. Patients who have been treated diet and exercise therapy alone, or patients who have never received drug therapy at baseline. 5. Patients who are able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have history or current serious diabetic complication. 2. Patients that insulin dependence is suspected. 3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder. 4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL.

Design outcomes

Primary

MeasureTime frame
Change from baseline in fasting and postprandial blood glucose at week 12 by meal tolerance test

Secondary

MeasureTime frame
Change from baseline in HbA1c, body weight, fasting and postprandial serum insulin, proinsulin/insulin ratio, serum adiponectin at week 12

Countries

Japan

Contacts

Public ContactDaisuke Ito

Ogawa Red Cross Hospital Department of Internal Medicine

dito@saitama-med.ac.jp0493-72-2333

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026