Overview

Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics

Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the effect of adding liraglutide to high dose insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated Type 2 diabetes with insulin requirements of > 100 units of insulin per day.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mountain Diabetes and Endocrine Center
Treatments:
Insulin
Insulin, Globin Zinc
Liraglutide
Criteria
Inclusion Criteria:

1. Male and female patients with Type 2 diabetes with HbA1c from 6.5 to 10% treated with
intensive insulin therapy (MDI or CSII, including U-500 insulin-treated patients)
using > 100 units of insulin, with or without a stable dose of oral insulin
sensitizing medications, for at least three months.

2. Aged 18 to 80 years.

3. Females of child-bearing potential must be using adequate form of contraception.

4. Patient willing to monitor BG four times daily, use CGM, and comply with study-related
protocol.

Exclusion Criteria:

1. Type 1 diabetes.

2. Use of any GLP-1 receptor agonist within previous three months.

3. Use of DPP-4 inhibitors or oral insulin secretagogues within the previous three
months.

4. Use of glucocorticoids (except inhaled).

5. Use of any experimental drug within previous three months.

6. Known or suspected allergy to liraglutide, Novolog or Levemir.

7. Personal or family history of medullary carcinoma of the thyroid or MEN-2.

8. Concomitant chronic renal disease with creatinine > 1.5%.

9. Concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis
or active cardiovascular disease except stable exertional angina).

10. Inability or unwillingness to monitor BG, use CGM, or comply with study protocol.

11. Women of child-bearing potential unwilling to use adequate contraception, intending to
become pregnant or breast-feeding.