The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)

NCT01610934 | Completed Phase 2 DMC

• 2 other identifiers: MODY-TREAT2012-000592-17
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.

Conditions

Maturity-onset Diabetes of the Young

Keywords

MODY; Monogenic diabetes; Non-autoimmune diabetes; MODY3

Outcome Measures

Primary Outcomes (1)

• Fasting Plasma Glucose

  Glycaemic control will be evaluated by FPG monitored twice weekly, 7-point PG profiles every two weeks and 3 blinded 48-hour continuous PG profiles (before randomisation and at the end of both treatment periods). The patients who will be their own controls, will randomly be assigned (after one week washout of usual antidiabetic treatment) to receive either liraglutide or glimepiride for 6 weeks, and after another one-week washout period treated with the opposite treatment for 6 weeks.

  14 weeks

Secondary Outcomes (5)

• Serum Fructosamine

  14 weeks

• Hypoglycemic events

  14 weeks

• Plasma concentrations of insulin and C-peptide

  14 weeks

• Plasma glucagon

  14 weeks

• Plasma concentrations of incretin hormones

  14 weeks

Study Arms (2)

liraglutide

EXPERIMENTAL

Drug: liraglutide

glimepiride

ACTIVE COMPARATOR

Drug: Glimepiride

Interventions

liraglutide DRUG

The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.8 mg liraglutide will remain on 1.2 mg of liraglutide. The injection is administered once daily in the morning.

Also known as: Victoza®

liraglutide

Glimepiride DRUG

At randomisation patients will be initiated on their pre-study daily dose of glimepiride minus 0.5 mg. After one week the dose will be titrated (see below). Drug naïve patients will be initiated on an initial dosage of glimepiride of 0.5 mg for one week. Thereafter, glimepiride is increased to 1.0 mg and after another one week to 1.5 mg, and there after further up to 3 mg (if the average FPG during one week is above 6 mM). The dose of glimepiride can be increased up to 4 mg if average FPG is above 6 mM and no symptoms of hypoglycaemia are observed.

Also known as: Amaryl®

glimepiride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian above 18 years of age
• Well characterised MODY3
• Body mass index (BMI) \> 19 kg/m2
• Normal haemoglobin (males \> 8.2 mM, females \> 7.2 mM)
• Normal blood pressure (\< 160/100 mmHg)
• Informed consent
• Capability to perform a light cycling test (heart rate 100-120 beats per minute during 30 minutes)
• Females: use of anticonception (IUC or hormonal)

You may not qualify if:

• Heart failure: New York Heart Association class III-IV
• Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine \> 130 µM and/or albuminuria
• Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) \> 2 × upper normal serum levels)
• Anaemia
• Acute or chronic pancreatitis
• Stroma or thyroid cancer
• Pregnancy or breast feeding
• Inability to complete the study
• Treatment naïve patients with HbA1c \< 7.0 %
• Treatment with medicine that can not be paused for 12 hours
• Known allergic reaction to study medication
• Intention to become pregnant
• Unwillingness to complete the protocol

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Novo Nordisk A/S: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Diabetes research Division, University Hospital Gentofte

Hellerup, 2900, Denmark

Location

Related Publications (1)

• Ostoft SH, Bagger JI, Hansen T, Pedersen O, Faber J, Holst JJ, Knop FK, Vilsboll T. Glucose-lowering effects and low risk of hypoglycemia in patients with maturity-onset diabetes of the young when treated with a GLP-1 receptor agonist: a double-blind, randomized, crossover trial. Diabetes Care. 2014 Jul;37(7):1797-805. doi: 10.2337/dc13-3007.

  PMID: 24929431 DERIVED

MeSH Terms

Conditions

Mason-Type Diabetes; Diabetes Mellitus, Type 2; Maturity-Onset Diabetes of the Young, Type 3

Interventions

Liraglutide; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Signe H Østoft, MD

  Diabetes Research Division, University Hospital Gentofte, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 4, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

DK (1)