Diabetes Mellitus, Type 2Phase 4NCT03970044
Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.
A Phase 4 study testing Exenatide 2 MG and Dapagliflozin 10 MG in people with Diabetes Mellitus, Type 2, run by Consano Clinical Research, LLC at 1 site in United States.
Trial summary
This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone. 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 2 MG and Dapagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2019to 1 Jun 2021
- 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
- Willing and able to give informed written consent prior to any tudy specific procedures
- Male or female, age 18 to 75 years
- Diagnosis of T2DM
- HbA1c >7.5% and <12% obtained at Screening
- Treated with a stable dose of metformin alone (>1500 mg/day) or max tolerated dose for at least 8 weeks prior to Screening
- Body mass index (BMI) <45 kg/m2
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- Women of childbearing potential (WOCBP), defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), must agree to use 2 medically accepted, effective methods of birth control (e.g., hormonal contraceptive, barrier contraceptive with additional spermicide, tubal ligation, or an intrauterine device) prior to IP administration and continuing throughout the study and continuing for 10 weeks after the intake of the last dose of IP
- Females who are postmenopausal must have been postmenopausal for >1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the patient's follicle-stimulating hormone level must be checked and must be elevated and consistent with postmenopausal levels (i.e., >40 IU/L); otherwise these patients must agree to use contraceptives listed above
- Males who are sexually active with WOCBP must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 10 weeks following the last intake of IP to prevent pregnancy in a partner
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previous enrolment in the present study
- Participation in a study within 30 days of planned enrolment in this study and at least 5 half-lives of the investigational product (IP) the patient received in a previous study
- Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of IP
- Women who are pregnant, breastfeeding, or plan to become pregnant during the course of the study
- History of taking OAD medications other than metformin, during the 8 weeks prior to screening, or have been on insulin therapy within 1 year of screening (with the exception of insulin therapy for rescue or use in gestational diabetes)
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- Treated with a GLP-1 receptor agonist within 6 months
- Have a condition that is a contraindicated for use of exenatide (Bydureon BCise), dapagliflozin (Farxiga) or metformin per FDA approved prescribing information
- History of diabetic ketoacidosis requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to screening
- An estimated glomerular filtration rate (eGFR <60 mL/min/1.73 m2 at Screening. A one-time repeat measurement is permitted at the discretion of the investigator, if the value is not consistent with prior values
- History of acute pancreatitis associated or not with using an anti-diabetic drug therapy
- Active liver disease and/or significant abnormal liver function defined as AST > 2 x ULN and/or ALT > 2x ULN and /or serum total bilirubin > 2.0 mg/dl
- History of frequent urinary and/or genital mycotic infections as determined by the investigator
- Uncontrolled thyroid disease as determined by the investigator
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Significant cardiovascular history, as determined per Investigator's discretion
- Ingestion of prescription or over-the-counter weight loss medications during the 3 months prior to screening
- Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) or chronically take drugs that directly reduce gastrointestinal motility
- Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid therapy may be enrolled)
- A history of prior amputation, peripheral vascular disease, or diabetic foot ulcers
- History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
- Any condition or clinically significant abnormality, which in the Investigator's opinion, may render the patient unable to complete the study or which may pose significant risk to the patient or successful completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
About this study
Official title: Effectiveness of Once-weekly Exenatide (BCise) Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.
This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
Read the detailed description
This is a Phase IV, single site, randomized, open-label, 3 treatment group, parallel study comparing BYDUREON-BCiseTM plus FARXIGATM to BYDUREON-BCiseTM alone and FARXIGATM alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
Patients who meet all inclusion and none of the exclusion criteria will enter a 1-week Lead-in Period, during which patients will be given a blood glucose meter and fitted with a blinded Continuous Glucose Monitor (CGM) and undergo a 14-day CGM assessment.
After the 1-week Lead-in Period, approximately 60 subjects will be randomized at a 1:1:1 ratio to one of three open-label treatment arms to achieve approximately 20 subjects per treatment arm.
The study consists of a 2-week Screening Period, a 1-week Lead-in Period, a 14-week open-label Treatment Period and a 10-week Follow-up Period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exenatide 2 MG, Dapagliflozin 10 MG
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide 2 MGDrug
Also called Bydureon, Bydureon BCise, Byetta
Glucagon-like peptide-1 receptor
Dapagliflozin 10 MGDrug
Also called Farxiga 10 MG
sodium-glucose co-transporter 2 (SGLT2) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Exenatide 2 mg plus Dapagaliflozin 10 mg | Experimental | Exenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment Receives: Drug: Exenatide 2 MG; Drug: Dapagliflozin 10 MG |
| Exenatide 2 mg | Active comparator | Exenatide extended release, 2 mg weekly, injected 14 weeks of treatment Receives: Drug: Exenatide 2 MG |
| Dapagaliflozin 10 mg | Active comparator | Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment Receives: Drug: Dapagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAGE
Compare the change in mean amplitude of glucose excursions from baseline to week 14
Measured: 14 weeks
Secondary outcomes (7)
Fasting Plasma Glucose
Change in fasting plasma glucose from baseline to week 14
Measured: 14 weeks
HbA1c
Change in HbA1c from baseline to week 14
Measured: 14 weeks
Weight
Change in weight from baseline to week 14
Measured: 14 weeks
Blood Pressure
Change in blood pressure from baseline to week 14
Measured: 14 weeks
Blood Glucose Variability
Variability in blood glucose from baseline to weeks 4, 10 and 14
Measured: 14 weeks
24 Hour Mean Blood Glucose
Change in 24 mean blood glucose at multiple time points
Measured: 17 weeks
Blood Glucose Time In Range
Measure the proportion of time patients who had plasma glucose measurements of: <70 mg/dL, >70 mg/dL and <180 mg/dL or >180 mg/dL
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start2 Jul 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consano Clinical Research, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970044
- Sponsor's protocol ID
- WCCR-2019-1
- Status last verified
- Aug 2021
- First submitted
- 29 May 2019
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Once-weekly Exenatide (BCise) Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.
- ClinicalTrials.gov ID
- NCT03970044
- Acronym / sponsor ID
- WCCR-2019-1
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Consano Clinical Research, LLCUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 31 May 2019 (actual)
- 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.
This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
Detailed description
This is a Phase IV, single site, randomized, open-label, 3 treatment group, parallel study comparing BYDUREON-BCiseTM plus FARXIGATM to BYDUREON-BCiseTM alone and FARXIGATM alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
Patients who meet all inclusion and none of the exclusion criteria will enter a 1-week Lead-in Period, during which patients will be given a blood glucose meter and fitted with a blinded Continuous Glucose Monitor (CGM) and undergo a 14-day CGM assessment.
After the 1-week Lead-in Period, approximately 60 subjects will be randomized at a 1:1:1 ratio to one of three open-label treatment arms to achieve approximately 20 subjects per treatment arm.
The study consists of a 2-week Screening Period, a 1-week Lead-in Period, a 14-week open-label Treatment Period and a 10-week Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exenatide 2 mg plus Dapagaliflozin 10 mg | Experimental | Drug: Exenatide 2 MG, Drug: Dapagliflozin 10 MGExenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment |
| Exenatide 2 mg | Active comparator | Drug: Exenatide 2 MGExenatide extended release, 2 mg weekly, injected 14 weeks of treatment |
| Dapagaliflozin 10 mg | Active comparator | Drug: Dapagliflozin 10 MGDapagliflozin, 10 mg once daily, orally 14 weeks of treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to give informed written consent prior to any tudy specific procedures
- Male or female, age 18 to 75 years
- Diagnosis of T2DM
- HbA1c >7.5% and <12% obtained at Screening
- Treated with a stable dose of metformin alone (>1500 mg/day) or max tolerated dose for at least 8 weeks prior to Screening
Key exclusion criteria (22 listed)
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previous enrolment in the present study
- Participation in a study within 30 days of planned enrolment in this study and at least 5 half-lives of the investigational product (IP) the patient received in a previous study
- Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of IP
- Women who are pregnant, breastfeeding, or plan to become pregnant during the course of the study
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 2 MGAlso: Bydureon, Bydureon BCise, ByettaGlucagon-like peptide-1 receptor | Drug | Exenatide 2 mg, Exenatide 2 mg plus Dapagaliflozin 10 mg |
| Dapagliflozin 10 MGAlso: Farxiga 10 MGsodium-glucose co-transporter 2 (SGLT2) inhibitor | Drug | Dapagaliflozin 10 mg, Exenatide 2 mg plus Dapagaliflozin 10 mg |
Primary outcome
MAGE
Time frame: 14 weeks
Compare the change in mean amplitude of glucose excursions from baseline to week 14
7 secondary outcomes
Fasting Plasma Glucose
Time frame: 14 weeks
HbA1c
Time frame: 14 weeks
Weight
Time frame: 14 weeks
Blood Pressure
Time frame: 14 weeks
Blood Glucose Variability
Time frame: 14 weeks
24 Hour Mean Blood Glucose
Time frame: 17 weeks
Blood Glucose Time In Range
Time frame: 14 weeks
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 30 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 MG and Dapagliflozin 10 MG in people with Diabetes Mellitus, Type 2, run by Consano Clinical Research, LLC 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 9 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: finished, as of the sponsor's last update on 30 Aug 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?
MAGE (time frame: 14 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 30 Aug 2021.