Study of Effectiveness of Liraglutide Added to High Dose... | NCT01654120

Studies
Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics

NCT01654120

Sponsor

Mountain Diabetes and Endocrine Center

Status

Completed

Last Update Posted

Feb 25, 2021Actual

Enrollment

37Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type II

Interventions

Liraglutide
Insulin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Dec 16, 2011

First Submission Date that Met QC Criteria

Jul 30, 2012

First Posted Date

Jul 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2021

Last Update Posted Date

Feb 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

40 subjects with Type 2 diabetes using > 100 units of insulin per day with or without metformin with HbA1c > 6.5% will be randomized into 2 treatment groups: treatment group will have liraglutide added to insulin and control group will have insulin uptitration only for 6 months. Primary endpoint to be compared between groups will be HbA1c at 6 months. Secondary endpoints will include weight, total daily insulin dose, percent time in euglycemic, hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (CGM), and effect on GlycoMark and hs-CRP. Safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
liraglutide plus insulin	Experimental	Patients were randomized to receive liraglutide plus insulin (LIRA) for 12 months.	Drug: Liraglutide Drug: 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

Name	Type	Description	Arm Group Labels	Other Names
Liraglutide	Drug	SC, 1.8mg,QD, six months to one year	liraglutide plus insulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c at six months	Glycemic control as measured by HbA1c	baseline and six months

Secondary Outcomes

Measure	Description	Time Frame
Hypoglycemia	The frequency and severity of hypoglycemia in each treatment arm by glucose meter download and by percent time spent in the hypoglycemic range (BG < 70 mg/dl) by CGM will be assessed at six and 12 months	6 months and 12 months
Total Daily Insulin Dose (TDID)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Wendy S Lane, MD	Mountain Diabetes and Endocrine Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mountain Diabetes and Endocrine Center		Asheville	North Carolina	28803	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide
D007328	Insulin
D000069057	Insulin Detemir
D061267	Insulin Aspart

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

Browse Leaves

Not provided

Browse Branches

Not provided