Liraglutide in the Treatment of Type 1 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/8/2015 |
| Start Date: | May 2012 |
| End Date: | March 2016 |
| Contact: | Sonja Williams |
| Email: | swilliams@kaleidahealth.org |
| Phone: | 716-626-7998 |
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 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.
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 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.
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
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