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Tests dapagliflozin with pioglitazone in type 1 diabetes using automated insulin pumps

Tests dapagliflozin plus pioglitazone in adults with type 1 diabetes.

Key facts

Who runs it
Dasman Diabetes Institute
Where
Doha, QatarSee the siteAlso in 2 other countries, 2 sites
Trial code
Registry title
Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?
Status
Not yet recruiting
Phase
Phase 4
People taking part
60 people, planned
Started
15 Sept 2025
Expected to end
15 Jan 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Dapagliflozin (DAPA)
  • Pioglitazone 45 mg
  • Placebo
Record updated
29 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 diabetes whose blood sugar is not well controlled and who use multiple daily insulin injections or an insulin pump. It tests dapagliflozin plus pioglitazone.

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
Type 1 diabetes with poor blood sugar control (HbA1c 7.0-11.0% (53–97 mmol/mol)). Fasting C-peptide below 0.7 ng/ml. Total daily insulin dose of 0.6 U/kg per day or more.
Earlier treatment
Multiple daily insulin injections (basal plus prandial) or an insulin pump. Stable insulin dose (±4 units) in the last three months.
Biomarker or test result
Fasting C-peptide below 0.7 ng/ml. HbA1c 7.0-11.0% (53–97 mmol/mol). eGFR 60 ml/min or higher.

Main reasons for not taking part

  • Not in good general health apart from diabetes
  • Weight not stable over the last 3 months (± 3 pounds (1 kg))
  • Taking part in an excessively heavy exercise program

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • 1) Age >18 years 2) T1DM 3) Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG
  • Fasting C-peptide concentration <0.7 ng/ml 5) Poor glycemic control (HbA1c=7.0-11.0%) 6) Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7) Total daily insulin dose ≥0.6 U/kg per day 8) Stable insulin dose (±4 units) in the preceding three months. 9) eGFR≥60 ml/min. 10) Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program

Who cannot take part

  • 1) Age >18 years 2) T1DM 3) Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG; Fasting C-peptide concentration <0.7 ng/ml 5) Poor glycemic control (HbA1c=7.0-11.0%) 6) Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7) Total daily insulin dose ≥0.6 U/kg per day 8) Stable insulin dose (±4 units) in the preceding three months. 9) eGFR≥60 ml/min. 10) Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program

Where in Qatar

Also in 2 other countries, 2 sites

  • Hamad Medical CorporationDoha, QatarContact: Khaled Ahmed Baagar, MDNo longer taking part

About the trial

What the trial wants to find out

Previous data from our clinical trial has demonstrated that the combination of dapagliflozin plus pioglitazone cause robust decrease in the plasma glucose concentration without significant increase in plasma ketone concentration in subjects with T1DM receiving multiple insulin injections or insulin pump. Although patients receiving insulin therapy with pump have participated in the study, none has insulin delivered in automated pump (780 pump) which automatically adjusts the rate of insulin infusion based upon the measured plasma glucose concentration. Although automated insulin pumps have been introduced to practice only last year, they are gaining popularity in the care of T1DM patients worldwide. The aim of this amendment is to demonstrate the efficacy (decrease in HbA1c) and safety (no significant increase in plasma ketone concentration) of combination of dapagliflozin plus pioglitazone in T1DM patients receiving insulin therapy with automated insulin pump.

The 2 groups in the trial

  • Pioglitazone and DapagliflozinExisting treatment, for comparison

    Group 1 will be started on dapagliflozin 10 mg per day plus 30 mg pioglitazone.

    Treatment: Dapagliflozin (DAPA) and Pioglitazone 45 mg

  • PlaceboPlacebo, for comparison

    Group 2 will receive matching placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?
Plain-language title
Tests dapagliflozin with pioglitazone in type 1 diabetes using automated insulin pumpsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 August 2025