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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518945
Recruitment Status : Unknown
Verified August 2015 by Nitesh D. Kuhadiya, University at Buffalo.
Recruitment status was:  Recruiting
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Nitesh D. Kuhadiya, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Dapagliflozin Drug: Insulin Drug: Liraglutide Drug: Dapagliflozin placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes. A Randomized Clinical Trial
Study Start Date : August 2015
Estimated Primary Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Placebo Comparator: Placebo
12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo"
Drug: Insulin
Other Name: Lantus, Levemir, Toujjeo, Humalog , Novolog, Apidra

Drug: Liraglutide
Victoza(Liraglutide) is a GLP-1 agent.
Other Name: Victoza

Drug: Dapagliflozin placebo
Dapagliflozin placebo looking similar to active drug Dapagliflozin in external appearance but not containing active ingredient dapagliflozin
Other Name: Placebo

Active Comparator: Active drugs
12 weeks of treatment with Insulin, Liraglutide and "Active Dapagliflozin Drug"
Drug: Dapagliflozin
Dapagliflozin or Farxiga is a SGLT-2 inhibitor
Other Name: Farxiga

Drug: Insulin
Other Name: Lantus, Levemir, Toujjeo, Humalog , Novolog, Apidra

Drug: Liraglutide
Victoza(Liraglutide) is a GLP-1 agent.
Other Name: Victoza




Primary Outcome Measures :
  1. To detect a difference from baseline in mean HbA1c before and after 12 weeks of addition of dapagliflozin compared to placebo. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Comparison of the time spent at glucose concentrations between 70-160; 160-240; 240--401; 55-70; <55 mg/dl before and after treatment with 12 weeks of dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks ]
  2. Comparison of 24-hour urine glucose excretion before and after 12 weeks of treatment of dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks. ]
  3. Comparison of the total daily insulin requirements in units and units per kilogram before and after treatment 12 weeks of dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks ]
  4. Comparison of Body weight in Kilograms before and after 12 weeks treatment with dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks ]
  5. Comparison of Systolic and diastolic blood pressure in mm Hg before and after 12 weeks treatment with dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks ]
  6. Comparison of Postprandial glucose concentrations following a test meal as areas under the curve for the data obtained from the meal challenge. before and after 12 weeks treatment with dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks ]
  7. Comparison of Carbohydrate intake in grams and in terms of carbohydrate helpings(frequency) before and after 12 weeks treatment with dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks ]
  8. Comparison of quality of life measures using Diabetes Specific Quality of Life Scale (DSQOLS) and problem areas in Diabetes survey (PAID) scores before and after 12 weeks treatment with dapagliflozin in addition to liraglutide and insulin. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518945


Contacts
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Contact: Nitesh D Kuhadiya, MD, MPH (716) 898-1950 nkuhadiya@gmail.com
Contact: Jeanne Hejna, LPN : (716) 898-1944 jeannehe@buffalo.edu

Locations
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United States, New York
ECMC Ambulatory Center, 3rd Floor Recruiting
Buffalo, New York, United States, 14215
Contact: Nitesh D Kuhadiya, MD, MPH    716-898-1940    nkuhadiya@gmail.com   
Contact: Jeanne Hejna, LPN    716-898-1944    jeannehe@buffalo.edu   
Sponsors and Collaborators
University at Buffalo
Investigators
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Principal Investigator: Nitesh D Kuhadiya, MD, MPH University at Buffalo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nitesh D. Kuhadiya, MD, MPH, University at Buffalo
ClinicalTrials.gov Identifier: NCT02518945    
Other Study ID Numbers: 1969
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Keywords provided by Nitesh D. Kuhadiya, University at Buffalo:
Type 1 Diabetes
Liraglutide
Dapagliflozin
Triple Therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liraglutide
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action