Phase 3 N=26 Randomized Quadruple-blind Treatment

Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes

Type 1 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT02518945 ↗

Enrolled (actual)

Serious AEs

7.7%

Results posted

Jan 2024

Primary outcome: Primary: Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo. — 0; -0.66 % HbA1c

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dapagliflozin (Drug); Insulin (Drug); Liraglutide (Drug); Dapagliflozin placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University at Buffalo
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo.	0; -0.66	—
SECONDARY Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dl	-1.4; 10	—
SECONDARY Change in 24-hour Urine Glucose Excretion.	2.1; 66.9	—
SECONDARY Change in Total Daily Insulin Requirements	-0.1; -3.5	—
SECONDARY Change in Body Weight	0.7; -1.9	—
SECONDARY Change in Systolic Blood Pressure Before and After Treatment	-2; -12	—
SECONDARY Change in Blood Ketone Bodies	-0.03; 0.20	—

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.

Eligibility Criteria

Inclusion Criteria

Patients with type 1 diabetes mellitus: Fasting c-peptide 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
Women who are pregnant
History of serious hypersensitivity reaction to these agents.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02518945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.