Liraglutide in the Treatment of Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kaleida Health
• Collaborator: Novo Nordisk A/S
• Treatments: Glucagon; Liraglutide

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