NCT01392898

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

July 4, 2011

Last Update Submit

August 1, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

liraglutideinsulintype 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Body weight change (measured body weight at 26 weeks minus baseline body weight)

    Measuring body weight after 26 weeks minus baseline body weight as the change in body weight after Liraglutide treatment.

    26 weeks (26 weeks - baseline)

Secondary Outcomes (1)

  • Measuring change in insulin dose (insulin dose at 26 weeks minus insulin dose at baseline)

    26 weeks (26 weeks -baseline)

Study Arms (2)

liraglutide

EXPERIMENTAL
Drug: liraglutide

insulin

ACTIVE COMPARATOR
Drug: Insulin

Interventions

liraglutideDRUG

liraglutide 1.8 mg q.d.

liraglutide
InsulinDRUG

insulin dosed according titration scheme

insulin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Related Publications (1)

  • de Wit HM, Vervoort GM, Jansen HJ, de Grauw WJ, de Galan BE, Tack CJ. Liraglutide reverses pronounced insulin-associated weight gain, improves glycaemic control and decreases insulin dose in patients with type 2 diabetes: a 26 week, randomised clinical trial (ELEGANT). Diabetologia. 2014 Sep;57(9):1812-9. doi: 10.1007/s00125-014-3302-0. Epub 2014 Jun 20.

    PMID: 24947583DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

LiraglutideInsulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProinsulinInsulinsPancreatic HormonesPeptide HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2011

First Posted

July 13, 2011

Study Start

February 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 2, 2013

Record last verified: 2011-07

Locations

NL(1)