Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes (ELEGANT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01392898
First received: July 4, 2011
Last updated: August 1, 2013
Last verified: July 2011
  Purpose

Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes. Although insulin is an effective treatment modality, this is often at the expense of significant weight gain. Weight gain is obviously undesirable in an already overweight population, but may also deter further optimization of insulin therapy. Large inter-individual differences exist in the level of weight gain after initiation of insulin therapy, but no clear predictive factors have prospectively been identified thus far.

Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic control and reduces weight. We hypothesize that in patients who show (excessive) weight gain after introducing insulin therapy, adding liraglutide is effective in reversing body weight while preserving glycaemic control.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: liraglutide
Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Liraglutide on Insulin-associated wEight GAiN in Patients With Type 2 Diabetes Mellitus (ELEGANT Trial)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Body weight change (measured body weight at 26 weeks minus baseline body weight) [ Time Frame: 26 weeks (26 weeks - baseline) ] [ Designated as safety issue: No ]
    Measuring body weight after 26 weeks minus baseline body weight as the change in body weight after Liraglutide treatment.


Secondary Outcome Measures:
  • Measuring change in insulin dose (insulin dose at 26 weeks minus insulin dose at baseline) [ Time Frame: 26 weeks (26 weeks -baseline) ] [ Designated as safety issue: No ]
    Change in insulin dose by measuring insulin dose at 26 weeks minus the insulin dose at baseline.


Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: liraglutide Drug: liraglutide
liraglutide 1.8 mg q.d.
Active Comparator: insulin Drug: Insulin
insulin dosed according titration scheme

Detailed Description:

Patients with type 2 diabetes mellitus on short-term (≤ 12 months) insulin therapy with concomitant documented weight gain of ≥ 4 % body weight will be selected and treated with liraglutide 1.8 mg sc q.d. for 26 weeks and compared to patients receiving standard care (continuation of insulin therapy without liraglutide) in an open-label, randomized study. After 26 weeks, patients receiving standard care will subsequently be treated with liraglutide for 26 weeks. The group on active liraglutide treatment will continue for an additional 26 weeks. In this way all patients can benefit from liraglutide.

All subjects will continue insulin therapy and oral hypoglycaemic agents (SU derivatives and metformin allowed) treatment. With respect to safety in order to avoid hypoglycaemic events, total insulin dose will be decreased by 20% when starting liraglutide. Within the first weeks after start of study medication patients will perform frequently self-measured capillary blood glucose profiles and will be instructed to adjust insulin dose if necessary. Initially, insulin dose will be adjusted weekly by telephone consultation. Thereafter, patients will perform blood glucose profiles prior to every outpatient visit. A liraglutide-insulin titration algorithm will be used to adjust insulin dose. Every 4-6 weeks patients will visit the hospital to assess body weight, to adjust insulin dose and to check for adverse events.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed
  • Documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion
  • Age 18-75 years
  • BMI ≥ 25 kg/m2
  • Stable glycaemic control mirrored by HbA1c ≥ 6.5 and ≤ 8.5 %

Exclusion Criteria:

  • Inability to provide informed consent
  • Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes (presence of anti-GAD)
  • Presence of any medical condition that might interfere with the current study protocol.
  • Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis)
  • Recurrent hypoglycaemic events
  • Diabetic gastroparesis
  • Heart failure (LVEF ≤ 30%)
  • Use of TZDs (glitazones), DDP-IV (dipeptidylpeptidase-inhibitor)
  • Use of medication associated with impaired glucose metabolism including corticosteroids
  • Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women)
  • Pre-existing thyroid disease
  • Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
  • Renal disease (creatinine > 130 µmol/l or MDRD-GFR <30 ml/min/1.73m2)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392898

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01392898     History of Changes
Other Study ID Numbers: Lir-HJCJ-03
Study First Received: July 4, 2011
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Radboud University:
liraglutide
insulin
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Liraglutide
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 August 21, 2014