Diabetes Mellitus, Type IIPhase 4NCT01654120
Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics
A Phase 4 study testing Liraglutide and Insulin in people with Diabetes Mellitus, Type II, run by Mountain Diabetes and Endocrine Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Liraglutide and Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
About this study
Official title: Liraglutide and Insulin-001 A Randomized Prospective Trial of Liraglutide Added to High-Dose Insulin Therapy vs. High-Dose Insulin Therapy Alone in Insulin-Resistant Patients With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Liraglutide, Insulin
- Keywords
- insulin, Type II Diabetes, liraglutide, Glucagon-Like Peptide 1
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
SC, 1.8mg,QD, six months to one year
InsulinDrug
Also called U-500, Levemir, Novolog
SC, will be titrated during the study, 4 times a day, 1 year
| Study group | Role | What they receive |
|---|---|---|
| liraglutide plus insulin | Experimental | Patients were randomized to receive liraglutide plus insulin (LIRA) for 12 months. Receives: 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. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at six months
Glycemic control as measured by HbA1c
Measured: baseline and six months
Secondary outcomes (4)
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
Measured: 6 months and 12 months
Total Daily Insulin Dose (TDID)
TDID will be determined in each treatment arm for statistical comparisons at three and six months, and for entire cohort at nine and 12 months.
Measured: 3, 6, 9, and 12 months
Weight
Weight will be statistically compared to baseline and between treatment arms at three and six months, and for entire cohort between baseline, six, nine and 12 months.
Measured: baseline, 3, 6, 9, and 12 months
GlycoMark
Postprandial glycemic control as assessed by GlycoMark and CGM will be compared between study groups at three and six months, and for entire cohort compared to baseline at nine and 12 months.
Measured: baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mountain Diabetes and Endocrine Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy S Lane, MD, Principal investigator, Mountain Diabetes and Endocrine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654120
- Sponsor's protocol ID
- high dose and lira 001
- Status last verified
- Feb 2021
- First submitted
- 16 Dec 2011
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide and Insulin-001 A Randomized Prospective Trial of Liraglutide Added to High-Dose Insulin Therapy vs. High-Dose Insulin Therapy Alone in Insulin-Resistant Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01654120
- Acronym / sponsor ID
- high dose and lira 001
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- insulin, Type II Diabetes, liraglutide, Glucagon-Like Peptide 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mountain Diabetes and Endocrine CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liraglutide plus insulin | Experimental | Drug: Liraglutide, Drug: InsulinPatients were randomized to receive liraglutide plus insulin (LIRA) for 12 months. |
| Insulin titration only | Active comparator | Drug: InsulinPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: VictozaSC, 1.8mg,QD, six months to one year | Drug | liraglutide plus insulin |
| InsulinAlso: U-500, Levemir, NovologSC, will be titrated during the study, 4 times a day, 1 year | Drug | Insulin titration only, liraglutide plus insulin |
Primary outcome
Change from baseline in HbA1c at six months
Time frame: baseline and six months
Glycemic control as measured by HbA1c
4 secondary outcomes
Hypoglycemia
Time frame: 6 months and 12 months
Total Daily Insulin Dose (TDID)
Time frame: 3, 6, 9, and 12 months
Weight
Time frame: baseline, 3, 6, 9, and 12 months
GlycoMark
Time frame: baseline, 3, 6, 9, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy S Lane, MD principal investigator
Mountain Diabetes and Endocrine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and Insulin in people with Diabetes Mellitus, Type II, run by Mountain Diabetes and Endocrine Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HbA1c at six months (time frame: baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.