Diabetes Mellitus, Type 2Phase 4DexlarNCT02811484
Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes
A Phase 4 study testing Exenatide-LAR plus Dapagliflozin, Insulin Titration and Behavioral Therapy in people with Diabetes Mellitus, Type 2, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exenatide-LAR plus Dapagliflozin, Insulin Titration and Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 diabetes
- BMI ≥27kg/m^2
- Hemoglobin A1C 8-12%
- English speaking
- provided written consent
- on a stable dose of metformin and/or glitazone and/or alpha-glucosidase inhibitors for ≥ to 8 weeks
Who cannot join
- History of type 1 diabetes
- fasting c-peptide <.8 ng/ml
- eGFR <60 ml/min/1.73 m^2
- urine albumin-to-creatinine ratio greater or equal to 300 mg/g
- AST/ALT greater or equal to 2.5 upper limits of normal
- history of infectious liver disease (HBV, HCV)
Show all 22Show fewer
- creatine kinase greater or equal to 3 times the upper limits of normal
- unstable or serious cardiovascular, renal, or hepatic disease
- symptoms of severely uncontrolled diabetes
- history of more than 1 episode of severe/major hypoglycemia within 6 months, active/history of bladder cancer
- female patients who are pregnant or intending to become pregnant
- women who are breastfeeding
- personal/family history of medullary thyroid cancer or MEN2
- fasting triglyceride levels > 500 mg/dl
- history of confirmed pancreatitis
- known hypersensitivity or allergy to exenatide or dapagliflozin
- are currently enrolled in or discontinued within last 30 days from another study
- have any other condition that precludes the patient from following and completing the protocol
- history of diabetic ketoacidosis
- anti-diabetes medication other than those listed in the inclusion criteria within 8 weeks of screening
- history of previous bariatric surgery or planned bariatric surgery during the course of the study
- clinically significant abnormal free T4/TSH requiring initiation or adjustment of thyroid treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Weight Control Center
New York, New York, 10065
About this study
Official title: Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes
The purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin. This research study is being done to investigate which of these commonly-used medications, medication combinations or increasing insulin dose is better.
Read the detailed description
This is a single center prospective, randomized, placebo-controlled trial in overweight/obese patients with insulin treated uncontrolled type 2 diabetes
Eligible subjects willing to participate in the study will be randomized to one of 3 treatment groups:
Group 1: Insulin titration + behavioral therapy Basal insulin titration upto 12 weeks with 2 U increment every 3 days (Fasting glucose goal <110) based on self-monitored blood glucose.
After 12 weeks, patients with HbA1c >8% will switch to a basal bolus regimen.
Group 2: Exenatide-LAR 2mg q week x 24 weeks + Dapagliflozin placebo x 52 weeks + titrated basal insulin +behavioral therapy.
Group 3: Exenatide-LAR 2mg q week x 24 weeks plus Dapagliflozin 5mg QD x 2 weeks followed by 10mg QD x22 weeks +titrated basal insulin + behavioral therapy.
Behavioral therapy will be delivered by registered dietitians and will include the BMIQ program -a web based medical weight loss program.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exenatide-LAR plus Dapagliflozin placebo, Exenatide-LAR plus Dapagliflozin, Insulin Titration, Behavioral Therapy
- Keywords
- Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide-LAR plus Dapagliflozin placeboDrug
Also called Bydureon, Farxiga
Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.
Exenatide-LAR plus DapagliflozinDrug
Also called Bydureon, Farxiga
Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin 5 mg x 2 weeks, then 10 mg for 22 weeks and behavioral therapy.
Insulin TitrationDrug
Also called Lantus, Levemir, Novolog, Lispro
Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
Behavioral TherapyBehavioural
Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Insulin titration and behavioral therapy. Receives: Drug: Insulin Titration; Behavioral: Behavioral Therapy |
| Group 2 | Placebo comparator | Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy. Receives: Drug: Exenatide-LAR plus Dapagliflozin placebo; Drug: Insulin Titration; Behavioral: Behavioral Therapy |
| Group 3 | Experimental | Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy. Receives: Drug: Exenatide-LAR plus Dapagliflozin; Drug: Insulin Titration; Behavioral: Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
To determine the efficacy of Exenatide-LAR and Exenatide-LAR plus dapagliflozin in lowering HbA1c compared with insulin titration in obese, insulin treated subjects with uncontrolled Type 2 Diabetes Mellitus at 24 weeks
Measured: baseline, 24 weeks
Secondary outcomes (6)
Change in Body Weight
To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on body weight in obese, insulin treated subjects with uncontrolled T2DM
Measured: baseline, 24 weeks
Change in waist circumference
To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on waist circumference in obese, insulin treated subjects with uncontrolled T2DM
Measured: baseline, 24 weeks
Change in fasting glucose
To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting glucose (FG) in obese, insulin treated subjects with uncontrolled T2DM
Measured: baseline, 24 weeks
Change in fasting lipids
To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting lipids in obese, insulin treated subjects with uncontrolled T2DM
Measured: baseline, 24 weeks
Change in blood pressure
To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on blood pressure in obese, insulin treated subjects with uncontrolled T2DM
Measured: baseline, 24 weeks
Change in total dose insulin
To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on total dose insulin in obese, insulin treated subjects with uncontrolled T2DM
Measured: baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Inability to enroll due to the widespread use of both classes of drugs in patients with T2DM, including those on concomitant insulin therapy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alpana P Shukla, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811484
- Sponsor's protocol ID
- 1512016843
- Acronym
- Dexlar
- Status last verified
- Mar 2017
- First submitted
- 17 Jun 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02811484
- Acronym / sponsor ID
- Dexlar / 1512016843
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to enroll due to the widespread use of both classes of drugs in patients with T2DM, including those on concomitant insulin therapy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Jun 2016 (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 see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin. This research study is being done to investigate which of these commonly-used medications, medication combinations or increasing insulin dose is better.
Detailed description
This is a single center prospective, randomized, placebo-controlled trial in overweight/obese patients with insulin treated uncontrolled type 2 diabetes
Eligible subjects willing to participate in the study will be randomized to one of 3 treatment groups:
Group 1: Insulin titration + behavioral therapy Basal insulin titration upto 12 weeks with 2 U increment every 3 days (Fasting glucose goal <110) based on self-monitored blood glucose.
After 12 weeks, patients with HbA1c >8% will switch to a basal bolus regimen.
Group 2: Exenatide-LAR 2mg q week x 24 weeks + Dapagliflozin placebo x 52 weeks + titrated basal insulin +behavioral therapy.
Group 3: Exenatide-LAR 2mg q week x 24 weeks plus Dapagliflozin 5mg QD x 2 weeks followed by 10mg QD x22 weeks +titrated basal insulin + behavioral therapy.
Behavioral therapy will be delivered by registered dietitians and will include the BMIQ program -a web based medical weight loss program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Insulin Titration, Behavioral: Behavioral TherapyInsulin titration and behavioral therapy. |
| Group 2 | Placebo comparator | Drug: Exenatide-LAR plus Dapagliflozin placebo, Drug: Insulin Titration, Behavioral: Behavioral TherapyExenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy. |
| Group 3 | Experimental | Drug: Exenatide-LAR plus Dapagliflozin, Drug: Insulin Titration, Behavioral: Behavioral TherapyExenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Type 2 diabetes
- BMI ≥27kg/m^2
- Hemoglobin A1C 8-12%
- English speaking
- provided written consent
Key exclusion criteria (22 listed)
- History of type 1 diabetes
- fasting c-peptide <.8 ng/ml
- eGFR <60 ml/min/1.73 m^2
- urine albumin-to-creatinine ratio greater or equal to 300 mg/g
- AST/ALT greater or equal to 2.5 upper limits of normal
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 |
|---|---|---|
| Exenatide-LAR plus Dapagliflozin placeboAlso: Bydureon, FarxigaExenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy. | Drug | Group 2 |
| Exenatide-LAR plus DapagliflozinAlso: Bydureon, FarxigaExenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin 5 mg x 2 weeks, then 10 mg for 22 weeks and behavioral therapy. | Drug | Group 3 |
| Insulin TitrationAlso: Lantus, Levemir, Novolog, LisproBasal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8% | Drug | Group 1, Group 2, Group 3 |
| Behavioral TherapySubjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program. | Behavioural | Group 1, Group 2, Group 3 |
Primary outcome
Change in HbA1c
Time frame: baseline, 24 weeks
To determine the efficacy of Exenatide-LAR and Exenatide-LAR plus dapagliflozin in lowering HbA1c compared with insulin titration in obese, insulin treated subjects with uncontrolled Type 2 Diabetes Mellitus at 24 weeks
6 secondary outcomes
Change in Body Weight
Time frame: baseline, 24 weeks
Change in waist circumference
Time frame: baseline, 24 weeks
Change in fasting glucose
Time frame: baseline, 24 weeks
Change in fasting lipids
Time frame: baseline, 24 weeks
Change in blood pressure
Time frame: baseline, 24 weeks
Change in total dose insulin
Time frame: baseline, 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Alpana P Shukla, MD principal investigator
Weill Medical College of Cornell University
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 Exenatide-LAR plus Dapagliflozin, Insulin Titration and Behavioral Therapy in people with Diabetes Mellitus, Type 2, run by Weill Medical College of Cornell University 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 6 inclusion and 22 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: withdrawn, as of the sponsor's last update on 3 Mar 2017. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 in HbA1c (time frame: baseline, 24 weeks). 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 3 Mar 2017.