Liraglutide as add-on to Insulin in Type 1 Diabetes

NCT02092896 | Completed Phase 3 DMC

• 1 other identifier: 2012-002526-67
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Cognitive performance; Hypoglycemia; Insulin; Glucagon-Like Peptide 1; Hypoglycemic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Incretins; Hormones

Outcome Measures

Primary Outcomes (3)

• Change from baseline in HbA1c (glycosylated haemoglobin)

  Week 0, week 12

• Changes from baseline in EEG and cognitive performances

  week 0, week 12

• Change from baseline in gastric emptying rate

  week 0, week 12

Secondary Outcomes (7)

• Change from baseline in glycemic control (CGM)

  week 0, week 12

• Change from baseline in total daily insulin dose

  week 0, week 12

• Changes from baseline in the counterregulatory hormone responses during hypoglycemia

  week 0, week 12

• Change from baseline in body weight

  week 0, week 12

• Change from baseline in auditory evoked potentials (AEP) during hypoglycemia

  week 0, week 12

Other Outcomes (1)

• Frequency of Hypoglycemic episodes

  Week 0, week 12

Study Arms (4)

Placebo + Insulin + Study 2

PLACEBO COMPARATOR

Study 2: Cognitive performance test

Drug: Liraglutide

Liraglutide + Insulin + Study 2

EXPERIMENTAL

Study 2: Cognitive performance test

Drug: Placebo

Liraglutide + Insulin + Study 1

EXPERIMENTAL

Study 1: Gastric emptying test

Drug: Liraglutide

Placebo + Insulin + Study 1

PLACEBO COMPARATOR

Study 1: Gastric emptying test

Drug: Placebo

Interventions

Liraglutide DRUG

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.

Liraglutide + Insulin + Study 1

Placebo DRUG

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.

Placebo + Insulin + Study 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years
• BMI: 18-28
• HbA1c ≥ 8 %
• No residual β-cell function (glucagon test with c-peptide \< 60 pM)
• Caucasian
• Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
• Remission phase must be completed
• Female participants must use adequate contraception
• Informed consent

You may not qualify if:

• Overt diabetes complications; creatinin \> 130 µM, proliferative retinopathy, macroalbuminuria.
• Autonomic neuropathy (RR-variation \</=10 beats/min) and/or Orthostatic hypotension (OH).
• Anemia, Hb concentration; female \<7.0 mmol/l, male\<8.0 mmol/l
• Pregnancy or lactation
• Epilepsy
• Use of antiepileptic medication
• Use of beta blockers
• Previously apoplexy cerebri.
• Any use of benzodiazepine within the last month
• Any use of neuroleptic drugs within the last six months
• Self-perceived hearing loss
• Alcohol or drug abuse
• Allergy to the medication or placebo.
• Treatment with any medication affecting glucose metabolism.
• Any disorder which in the investigators opinion could interfere with the safety and results of the trial

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• NNF Center for Basal Metabolic Research, Denmark: collaborator
• Hillerod Hospital, Denmark: collaborator
• Danish PhD schools of Molecular Metabolism and Endocrinology: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Dept. of Endocrinology, Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

• Frandsen CS, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S. Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study. Diabetes Care. 2015 Dec;38(12):2250-7. doi: 10.2337/dc15-1037. Epub 2015 Oct 20.

  PMID: 26486191 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia; Insulin Resistance

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christian SS Frandsen, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: March 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

DK (1)