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Liraglutide in the Treatment of Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01722266
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health

Brief Summary:

Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting, postprandial and the overall mean glucose concentrations.

Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. In addition, the time spent at glucose concentrations >150 and 200mg/dl and <70 and <40 mg/dl will also be compared.

Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose concentrations will be measured as areas under the curve for the data obtained from the meal challenge.

Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases postprandial glucagon concentrations and increases postprandial C-peptide concentrations.

Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 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 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Liraglutide in the Treatment of Type 1 Diabetes Mellitus
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Placebo Comparator: Placebo
Daily Injection
Drug: Placebo

Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.

Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.


Active Comparator: Liraglutide 1.8mg
Daily Injection
Drug: Liraglutide

Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.

Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Other Name: Victoza

Active Comparator: Liraglutide 1.2mg
Daily injections
Drug: Liraglutide

Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.

Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Other Name: Victoza

Active Comparator: Liraglutide 0.6 mg
Daily injection
Drug: Liraglutide

Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.

Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Other Name: Victoza




Primary Outcome Measures :
  1. Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks [ Time Frame: 12 Weeks ]
    The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.


Secondary Outcome Measures :
  1. Change in HbA1c From Baseline at 12 Weeks [ Time Frame: Baseline and 12 Weeks ]
  2. Change in Body Weight From Baseline at Week 12 [ Time Frame: Baseline and 12 weeks ]
  3. Change in Total Insulin Dose From Baseline at 12 Weeks [ Time Frame: Baseline and 12 weeks ]
    Total insulin dose = Basal insulin dose plus bolus insulin dose.

  4. Percent Time Spent in Hyperglycemia and Hypoglycemia [ Time Frame: 12 weeks ]
  5. Reduction in the Area Under Curve(AUC) of Glucose Following the Meal [ Time Frame: 12 weeks ]
  6. Serum Acetaminophen Concentrations Following Meal Challenge [ Time Frame: 12 weeks ]
  7. Carbohydrate Intake [ Time Frame: 12 weeks ]
  8. Insulin, C-peptide, Glucagon, GLP-1(Glucagon Like Peptide-1) and GIP(Gastric Inhibitory Polypeptide) Concentrations Following Meal Challenge. [ Time Frame: 12 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:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily
  3. HbA1c of less than 8.5%.
  4. Well versed with carbohydrate counting
  5. Age 18-75 years

Exclusion Criteria:

  1. Type 1 diabetes for less than 12 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 creatinine > 1.5);
  5. HIV or Hepatitis 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.
  14. Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer
  15. Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant

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): NCT01722266


Locations
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United States, New York
Diabetes-Endocrinology Center of Western NY
Williamsville, New York, United States, 14221
Sponsors and Collaborators
Kaleida Health
Novo Nordisk A/S
Investigators
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Principal Investigator: Paresh Dandona, MBBS, PhD Kaleida Health

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paresh Dandona, MD, Distinguished Professor of Medicine, Kaleida Health
ClinicalTrials.gov Identifier: NCT01722266     History of Changes
Other Study ID Numbers: NN1962
First Posted: November 6, 2012    Key Record Dates
Results First Posted: March 13, 2015
Last Update Posted: March 13, 2015
Last Verified: March 2015
Keywords provided by Paresh Dandona, MD, Kaleida Health:
Liraglutide
Glucagon
Systolic blood pressure
Weight
Carbohydrate intake
Insulin dose
HbA1c
Post-prandial glucagon
Additional relevant MeSH terms:
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Liraglutide
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents