Skip to main content
OpenTrials
Completed

NCT Number: NCT01654120

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type II Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Aged 18 to 80 years.
  • Females of child-bearing potential must be using adequate form of contraception.
  • Patient willing to monitor BG four times daily, use CGM, and comply with study-related protocol.

Exclusion criteria

  • Type 1 diabetes.
  • Use of any GLP-1 receptor agonist within previous three months.
  • Use of DPP-4 inhibitors or oral insulin secretagogues within the previous three months.
  • Use of glucocorticoids (except inhaled).
  • Use of any experimental drug within previous three months.
  • Known or suspected allergy to liraglutide, Novolog or Levemir.
  • Personal or family history of medullary carcinoma of the thyroid or MEN-2.
  • Concomitant chronic renal disease with creatinine > 1.5%.
  • Concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis or active cardiovascular disease except stable exertional angina).
  • Inability or unwillingness to monitor BG, use CGM, or comply with study protocol.
  • Women of child-bearing potential unwilling to use adequate contraception, intending to become pregnant or breast-feeding.

Treatment and study plan

liraglutide

Drug

SC, 1.8mg,QD, six months to one year

Other names: Victoza

Insulin

Drug

SC, will be titrated during the study, 4 times a day, 1 year

Other names: U-500, Levemir, Novolog

Primary outcomes

  1. Change from baseline in HbA1c at six months

    Time frame: baseline and six months

    Glycemic control as measured by HbA1c

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Mountain Diabetes and Endocrine Center

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 31, 2012
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.