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

This study has been completed.
Information provided by (Responsible Party):
Mountain Diabetes and Endocrine Center Identifier:
First received: December 16, 2011
Last updated: April 16, 2015
Last verified: November 2013
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
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:

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 ]
    Glycemic control as measured by HbA1c

Secondary Outcome Measures:
  • Hypoglycemia [ Time Frame: 6 months and 12 months ]
    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 ]
    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 ]
    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 ]
    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
Study Completion Date: November 2013
Primary Completion Date: November 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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01654120

United States, North Carolina
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803
Sponsors and Collaborators
Mountain Diabetes and Endocrine Center
Principal Investigator: Wendy S Lane, MD Mountain Diabetes and Endocrine Center
  More Information

Responsible Party: Mountain Diabetes and Endocrine Center Identifier: NCT01654120     History of Changes
Other Study ID Numbers: high dose and lira 001
Study First Received: December 16, 2011
Last Updated: April 16, 2015

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 26, 2017