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

Diabetes Mellitus, Type II Clinical Trial

Official title:

Liraglutide and Insulin-001 A Randomized Prospective Trial of Liraglutide Added to High-Dose Insulin Therapy vs. High-Dose Insulin Therapy Alone in Insulin-Resistant Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654120
• Other study ID #: high dose and lira 001
• Status: Completed
• Phase: Phase 4
• Start date: December 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2021
• Source: Mountain Diabetes and Endocrine Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

40 subjects with Type 2 diabetes using > 100 units of insulin per day with or without metformin with HbA1c > 6.5% will be randomized into 2 treatment groups: treatment group will have liraglutide added to insulin and control group will have insulin uptitration only for 6 months. Primary endpoint to be compared between groups will be HbA1c at 6 months. Secondary endpoints will include weight, total daily insulin dose, percent time in euglycemic, hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (CGM), and effect on GlycoMark and hs-CRP. Safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• Liraglutide
SC, 1.8mg,QD, six months to one year
• Insulin
SC, will be titrated during the study, 4 times a day, 1 year

Locations

Country	Name	City	State
United States	Mountain Diabetes and Endocrine Center	Asheville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mountain Diabetes and Endocrine Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at six months	Glycemic control as measured by HbA1c	baseline and six months
Secondary	Hypoglycemia	The frequency and severity of hypoglycemia in each treatment arm by glucose meter download and by percent time spent in the hypoglycemic range (BG < 70 mg/dl) by CGM will be assessed at six and 12 months	6 months and 12 months
Secondary	Total Daily Insulin Dose (TDID)	TDID will be determined in each treatment arm for statistical comparisons at three and six months, and for entire cohort at nine and 12 months.	3, 6, 9, and 12 months
Secondary	Weight	Weight will be statistically compared to baseline and between treatment arms at three and six months, and for entire cohort between baseline, six, nine and 12 months.	baseline, 3, 6, 9, and 12 months
Secondary	GlycoMark	Postprandial glycemic control as assessed by GlycoMark and CGM will be compared between study groups at three and six months, and for entire cohort compared to baseline at nine and 12 months.	baseline, 3, 6, 9, and 12 months