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Dapagliflozin + Pioglitazone for Type 1 Diabetes

Phase 4
Recruiting
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable insulin dose (±4 units) in the preceding three months.
Total daily insulin dose ≥0.6 U/kg per day
Must not have
eGFR<60 ml/min
History of hypersensitivity to dapagliflozin or pioglitazone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is examining the effect of adding the diabetes drugs dapagliflozin and pioglitazone to insulin on glucose control and ketone levels in people with type 1 diabetes.

Who is the study for?
Adults over 18 with Type 1 Diabetes, HbA1c levels between 7.0-11.0%, and on a stable insulin dose can join this trial. They should be in good health, not heavily exercising, or planning pregnancy. Excluded are those sensitive to the drugs tested, with kidney issues (eGFR<60), other major diseases, recent severe diabetes complications, or on glucose-affecting meds besides insulin.
What is being tested?
The study tests if adding dapagliflozin and pioglitazone to insulin therapy improves blood sugar control in Type 1 Diabetes without increasing ketoacidosis or hypoglycemia risk. Participants will first take dapagliflozin for 12 weeks then randomly get either pioglitazone or placebo for another 16 weeks.
What are the potential side effects?
Possible side effects include sensitivity reactions to medication components, low blood sugar episodes (hypoglycemia), increased ketones which could lead to ketoacidosis (a serious condition where the body produces high levels of blood acids), and urinary issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My insulin dose has been stable for the last 3 months.
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I take 0.6 units or more of insulin per kilogram of my body weight daily.
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I am older than 18 years.
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I have been diagnosed with Type 1 Diabetes.
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I use an insulin pump or take multiple daily insulin injections.
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I have type 1 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is reduced.
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I am allergic to dapagliflozin or pioglitazone.
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I do not have major organ diseases, a history of serious illness, or take medication affecting glucose, other than insulin.
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I am using two forms of birth control.
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I have been diagnosed with type 2 diabetes.
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My daily insulin dose is less than 0.6 units per kilogram.
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I experience symptoms like excessive thirst or urination due to poor blood sugar control.
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I have a severe form of diabetic eye disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
insulin dose
plasma ketones

Side effects data

From 2013 Phase 3 trial • 936 Patients • NCT01183013
8%
Oedema peripheral
7%
Nasopharyngitis
7%
Hyperglycaemia
5%
Urinary tract infection
5%
Headache
5%
Dizziness
4%
Upper respiratory tract infection
4%
Arthralgia
4%
Back pain
4%
Pain in extremity
3%
Bronchitis
3%
Hypertension
1%
Retinal artery embolism
1%
Myocardial infarction
1%
Constipation
1%
Congestive cardiomyopathy
1%
Gastrointestinal haemorrhage
1%
Appendicitis
1%
Basal cell carcinoma
1%
Renal cell carcinoma
1%
Sleep apnoea syndrome
1%
Oedema
1%
Acute myocardial infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pio30/Pio30
Lina5Pio45/Lina5Pio45
Lina5/Lina5
Pio15/Pio30
Pio45/Pio45
Lina5Pio15/Lina5Pio30
Lina5Pio30/Lina5Pio30

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
pioglitazone treatment
Group II: controlPlacebo Group1 Intervention
subjects will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pioglitazone 45 mg
2000
Completed Phase 4
~960

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
477 Previous Clinical Trials
92,850 Total Patients Enrolled
7 Trials studying Diabetes
837 Patients Enrolled for Diabetes

Media Library

Pioglitazone 45 mg Clinical Trial Eligibility Overview. Trial Name: NCT03878459 — Phase 4
Diabetes Research Study Groups: control, Intervention
Diabetes Clinical Trial 2023: Pioglitazone 45 mg Highlights & Side Effects. Trial Name: NCT03878459 — Phase 4
Pioglitazone 45 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03878459 — Phase 4
~19 spots leftby Dec 2025
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