Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes
1 other identifier
interventional
26
1 country
1
Brief Summary
This is a single center, prospective, randomized, double blinded placebo controlled study conducted I patients with type 1 diabetes.The aim of this study is to examine the additive effects of GLP-1 agonist and SGLT2 inhibitor in patients with type 1 diabetes in terms of possible improved glycemic control, reduced glycemic variability, reduced insulin dosages, additional effects of weight loss and blood pressure reduction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
January 24, 2024
CompletedJanuary 24, 2024
December 1, 2023
4 months
July 31, 2015
December 30, 2023
December 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo.
T1D. Conservatively estimating a difference in mean HbA1c (the primary end point) of 0.5% before and after the treatment, and a sample size of 30 (2:1 drug to placebo ratio) should provide adequate power (.8) to detect a significant difference (.05) provided the standard deviation of the residuals in not greater than 0.4%. The sample size includes an additional 20% to account for the potential dropout. Changes in these end points were calculated by averaging the differences in weekly average values from baseline.
12 weeks
Secondary Outcomes (6)
Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dl
12 weeks
Change in 24-hour Urine Glucose Excretion.
12 weeks.
Change in Total Daily Insulin Requirements
12 weeks
Change in Body Weight
12 weeks
Change in Systolic Blood Pressure Before and After Treatment
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo"
Active drugs
ACTIVE COMPARATOR12 weeks of treatment with Insulin, Liraglutide and "Active Dapagliflozin Drug"
Interventions
Dapagliflozin placebo looking similar to active drug Dapagliflozin in external appearance but not containing active ingredient dapagliflozin
Eligibility Criteria
You may qualify if:
- Patients with type 1 diabetes mellitus: Fasting c-peptide \< 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis and treatment with liraglutide at maximal tolerated doses for at least 6 months prior to start of the study.
- Willing to use a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily
- HbA1c of less than or equal to 11%.
- Well versed with carbohydrate counting
- Age 18-75 years
You may not qualify if:
- Type 1 diabetes for less than 12 months.
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
- Hepatic disease (transaminase \> 3 times normal) or cirrhosis
- ESRD on hemodialysis; and or e-GFR less than 30 ml/min/1.73m2
- HIV or Hepatitis C positive status
- Participation in any other concurrent clinical trial
- Any other life-threatening, non-cardiac disease
- Use of an investigational agent or therapeutic regimen within 30 days of study
- History of pancreatitis
- Pregnancy
- Inability to give informed consent
- History of gastroparesis
- History of medullary thyroid carcinoma or MEN 2 syndrome
- Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer
- Women of childbearing potential who are not using adequate contraception
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ECMC Ambulatory Center, 3rd Floor
Buffalo, New York, 14215, United States
Related Publications (1)
Kuhadiya ND, Ghanim H, Mehta A, Garg M, Khan S, Hejna J, Torre B, Makdissi A, Chaudhuri A, Batra M, Dandona P. Dapagliflozin as Additional Treatment to Liraglutide and Insulin in Patients With Type 1 Diabetes. J Clin Endocrinol Metab. 2016 Sep;101(9):3506-15. doi: 10.1210/jc.2016-1451. Epub 2016 Aug 4.
PMID: 27490915DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paresh Dandona
- Organization
- State University of NY at Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Nitesh D Kuhadiya, MD, MPH
University at Buffalo
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 31, 2015
First Posted
August 10, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
January 24, 2024
Results First Posted
January 24, 2024
Record last verified: 2023-12