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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT02518945 (opens ClinicalTrials.gov in a new tab)Other id1969
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
26 participants (actual)
Sponsor
University at Buffalo · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Aug 2015
Primary completion
Dec 2015
Completion
Apr 2016
First posted
10 Aug 2015 (estimated)
Last update posted
24 Jan 2024
Conditions
Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 3

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

    NCT02518945

    Aug 2015 to Apr 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DapagliflozinDrug
  • InsulinDrug
  • LiraglutideDrug
  • Dapagliflozin placeboDrug

Arms2

  • Placebo comparator

    Placebo

    12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo"

  • Active comparator

    Active drugs

    12 weeks of treatment with Insulin, Liraglutide and "Active Dapagliflozin Drug"

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo.

    Time frame · 12 weeks

    Registry description

    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.

Secondary outcomes(6)

  1. Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dl

    Time frame · 12 weeks

    Registry description

    Comparison of the change in time spent at normal glucose concentrations between 70-180mg/dl after treatment with 12 weeks of dapagliflozin in addition to liraglutide and insulin.

  2. Change in 24-hour Urine Glucose Excretion.

    Time frame · 12 weeks.

    Registry description

    Comparison of change in 24-hour urine glucose excretion after 12 weeks of treatment of dapagliflozin in addition to liraglutide and insulin compared to baseline.

  3. Change in Total Daily Insulin Requirements

    Time frame · 12 weeks

    Registry description

    Comparison of the change from baseline in total daily insulin requirements in units per kilogram after treatment 12 weeks of dapagliflozin or placebo in addition to liraglutide and insulin.

  4. Change in Body Weight

    Time frame · 12 weeks

    Registry description

    Comparison of change from baseline in Body weight after 12 weeks treatment with dapagliflozin or placebo in addition to liraglutide and insulin.

  5. Change in Systolic Blood Pressure Before and After Treatment

    Time frame · 12 weeks

    Registry description

    Comparison of Systolic blood pressure in mm Hg before and after 12 weeks treatment with dapagliflozin in addition to liraglutide and insulin.

  6. Change in Blood Ketone Bodies

    Time frame · 12 weeks

    Registry description

    change from baseline in blood ketone bodies (measured as beta-hydroxybutyrates) after 12 weeks treatment with dapagliflozin or placebo in addition to liraglutide and insulin.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 weeks

Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo.

GroupValue (% HbA1c)Spread
Placebo00.2
Active Drugs-0.660.1
Secondary and other outcome results(6)
Secondary outcomeMean· 12 weeks

Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dl

GroupValue (percentage of time)Spread
Placebo-1.41.0
Active Drugs104
Secondary outcomeMean· 12 weeks.

Change in 24-hour Urine Glucose Excretion.

GroupValue (gram/day)Spread
Placebo2.11.1
Active Drugs66.94.7
Secondary outcomeMean· 12 weeks

Change in Total Daily Insulin Requirements

GroupValue (Units/Kg)Spread
Placebo-0.12.4
Active Drugs-3.51.9
Secondary outcomeMean· 12 weeks

Change in Body Weight

GroupValue (Kg)Spread
Placebo0.71.5
Active Drugs-1.90.5
Secondary outcomeMean· 12 weeks

Change in Systolic Blood Pressure Before and After Treatment

GroupValue (mmHg)Spread
Placebo-23
Active Drugs-124
Secondary outcomeMean· 12 weeks

Change in Blood Ketone Bodies

GroupValue (mM)Spread
Placebo-0.030.06
Active Drugs0.200.09

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo" Insulin Liraglutide: Victoza(Liraglutide) is a GLP-1 agent. Dapagliflozin placebo: Dapagliflozin placebo looking similar to active drug Dapagliflozin in external appearance but not containing active ingredient dapagliflozin–0 / 90 / 9
Active Drugs12 weeks of treatment with Insulin, Liraglutide and "Active Dapagliflozin Drug" Dapagliflozin: Dapagliflozin or Farxiga is a SGLT-2 inhibitor Insulin Liraglutide: Victoza(Liraglutide) is a GLP-1 agent.–2 / 170 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

10 results

Dapagliflozin as Additional Treatment to Liraglutide and Insulin in Patients With Type 1 Diabetes.

Kuhadiya et al. 2016The Journal of clinical endocrinology and metabolismcited by 52

PMID 27490915DOI 10.1210/jc.2016-1451PUB-27490915

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Women who are pregnant * History of serious hypersensitivity reaction to these agents.

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