Phase 3
Completed N=26
Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes
Source: ClinicalTrials.gov NCT02518945 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Jan 2024
Primary outcomePrimary: Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo. — 0; -0.66 % HbA1c
◆ Published Evidence
Established
69citations · ~7 / year
Dapagliflozin as Additional Treatment to Liraglutide and Insulin in Patients With Type 1 Diabetes.
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.
Linked Publications
-
Dapagliflozin as Additional Treatment to Liraglutide and Insulin in Patients With Type 1 Diabetes.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02518945) and the linked publication. 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. Informational only — not medical advice.