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Trial record 5 of 31 for:    Recruiting, Not yet recruiting, Available Studies | "Type 1 Diabetes" | NIDDK

Liraglutide in Type 1 Diabetes (1966)

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ClinicalTrials.gov Identifier: NCT01722240
Recruitment Status : Recruiting
First Posted : November 6, 2012
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo

Brief Summary:

The control of glucose homeostasis in subjects with type 1 diabetes is fragile since exogenous insulin cannot compensate for changing requirements and is not precise either in terms of the dose or the bio-availability of the insulin injected. Furthermore, in the near total absence of insulin secretion, the physiological post prandial inhibition of glucagon secretion by the α-cell is also probably deficient in all type 1 diabetics. Thus, there is a need for therapies beyond insulin that can further improve glycemic control and reduce fluctuations in glucose in these subjects. The investigators have recently shown that Liraglutide, a glucagon like peptide (GLP)-1 analogue with duration of action of 24 hours, when added to insulin in subjects with well controlled type 1 diabetes reduces mean and standard deviation of blood glucose, HbA1c and insulin requirements. Since C-peptide concentrations did not alter following Liraglutide, it is likely that the suppression of glucagon may have contributed to this effect. The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are:

Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required.

Aim 1.1: To compare the HbA1c, mean fasting, glucose, mean weekly glucose, standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring and the dose of insulin required prior to and following 52 weeks of treatment with 1.8 mg of liraglutide daily.

Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide daily.

Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations.

Aim 2.1: To compare the basal and postprandial glucagon and C-peptide concentrations following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide daily.

Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying.

Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and after treatment with 1.8 mg of daily subcutaneous liraglutide.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Liraglutide 1.8mg Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Liraglutide in Type 1 Diabetes
Study Start Date : November 2012
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutide 1.8mg
Daily Injection
Drug: Liraglutide 1.8mg
Placebo Comparator: Placebo
Daily Injection
Drug: Placebo



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 52 Weeks ]
    The primary endpoint of the study is to detect a difference in HbA1c after 52 weeks of treatment with Liraglutide or placebo.


Secondary Outcome Measures :
  1. Mean weekly glucose concentrations. [ Time Frame: 52 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day.
  2. Regularly measuring blood sugars four times daily.
  3. HbA1c of less than 8.5%.
  4. Well versed with carbohydrate counting.
  5. Age 18-75 years.
  6. BMI 20-40 kg/m2

Exclusion Criteria:

  1. Type 1 diabetes for less than 6 months;
  2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;
  3. Hepatic disease (transaminase > 3 times normal) or cirrhosis;
  4. Renal impairment (serum eGFR < 30ml/min/1.73m2);
  5. HIV or Hepatitis B or C positive status;
  6. Participation in any other concurrent clinical trial;
  7. Any other life-threatening, non-cardiac disease;
  8. Use of an investigational agent or therapeutic regimen within 30 days of study.
  9. history of pancreatitis
  10. pregnancy
  11. inability to give informed consent
  12. history of gastroparesis
  13. history of medullary thyroid carcinoma or MEN 2 syndrome.

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): NCT01722240


Contacts
Contact: Paresh Dandona, MD 7168981940 pdandona@kaleidahealth.org
Contact: Jeanne Hejna 716-898-1950

Locations
United States, New York
Diabetes-Endocrinology Center of WNY Recruiting
Buffalo, New York, United States, 14215
Contact: Jeanne Hejna, LPN    716-898-1950    jeannehe@buffalo.edu   
Principal Investigator: Paresh Dandona, MBBS,PhD         
Sponsors and Collaborators
University at Buffalo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Paresh Dandona, MBBS, PhD Kaleida Health

Responsible Party: Paresh Dandona, Director, Diabetes-Endocrinology Center of Western NY, University at Buffalo
ClinicalTrials.gov Identifier: NCT01722240     History of Changes
Other Study ID Numbers: 1966
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists