NCT01654120

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

December 16, 2011

Last Update Submit

February 23, 2021

Conditions

Diabetes Mellitus, Type II

Keywords

insulinType II DiabetesliraglutideGlucagon-Like Peptide 1

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at six months

    Glycemic control as measured by HbA1c

    baseline and six months

Secondary Outcomes (4)

  • Hypoglycemia

    6 months and 12 months

  • Total Daily Insulin Dose (TDID)

    3, 6, 9, and 12 months

  • Weight

    baseline, 3, 6, 9, and 12 months

  • GlycoMark

    baseline, 3, 6, 9, and 12 months

Study Arms (2)

liraglutide plus insulin

EXPERIMENTAL

Patients were randomized to receive liraglutide plus insulin (LIRA) for 12 months.

Drug: LiraglutideDrug: Insulin

Insulin titration only

ACTIVE COMPARATOR

Patients were randomized to receive insulin only (control) for 6 months. The controls were then crossed over to receive liraglutide plus insulin for 6 months after the initial control period.

Drug: Insulin

Interventions

LiraglutideDRUG

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

Also known as: Victoza
liraglutide plus insulin
InsulinDRUG

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

Also known as: U-500, Levemir, Novolog
Insulin titration onlyliraglutide plus insulin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

LiraglutideInsulinInsulin DetemirInsulin Aspart

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 ProteinsInsulin, Long-ActingInsulin, Short-Acting

Study Officials

  • Wendy S Lane, MD

    Mountain Diabetes and Endocrine Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

July 31, 2012

Study Start

December 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

US(1)