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

This study is currently recruiting participants.
Verified July 2012 by Mountain Diabetes and Endocrine Center
Sponsor:
Information provided by (Responsible Party):
Mountain Diabetes and Endocrine Center
ClinicalTrials.gov Identifier:
NCT01654120
First received: December 16, 2011
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type II
 Drug: Liraglutide
Drug: Insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mountain Diabetes and Endocrine Center:

Primary Outcome Measures:
  • Change from baseline in HbA1c at six months [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
    Glycemic control as measured by HbA1c


Secondary Outcome Measures:
  • Hypoglycemia [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
    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

  • Total Daily Insulin Dose (TDID) [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    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.

  • Weight [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    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.

  • GlycoMark [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: liraglutide plus insulin Drug: Liraglutide
SC, 1.8mg,QD, six months to one year
Other Name: Victoza
Drug: Insulin
SC, will be titrated during the study, 4 times a day, 1 year
Other Names:
  • U-500
  • Levemir
  • Novolog
Active Comparator: Insulin titration only Drug: Insulin
SC, will be titrated during the study, 4 times a day, 1 year
Other Names:
  • U-500
  • Levemir
  • Novolog

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654120

Contacts
Contact: Wendy S Lane, MD 828-258-2404 mountaindiabetes@msn.com
Contact: Stephen L Weinrib, MD 828-258-2404 slcweinrib@charter.net

Locations
United States, North Carolina
Mountain Diabetes and Endocrine Center Recruiting
Asheville, North Carolina, United States, 28803
Contact: Wendy S Lane, MD     828-258-2404     mountaindiabetes@msn.com    
Contact: Jonathan M Rappaport, MD     828-258-2404     drjonrap@yahoo.com    
Sponsors and Collaborators
Mountain Diabetes and Endocrine Center
Investigators
Principal Investigator: Wendy S Lane, MD Mountain Diabetes and Endocrine Center
  More Information

No publications provided

Responsible Party: Mountain Diabetes and Endocrine Center
ClinicalTrials.gov Identifier: NCT01654120     History of Changes
Other Study ID Numbers: high dose and lira 001
Study First Received: December 16, 2011
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mountain Diabetes and Endocrine Center:
insulin
Type II Diabetes
liraglutide
Glucagon-Like Peptide 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Glucagon-Like Peptide 1
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013