Type 1 Diabetes MellitusPhase 2ISLE-1NCT02794155
Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)
A Phase 2 study testing HDV Insulin Lispro and Insulin LISPRO in people with Type 1 Diabetes Mellitus, run by Diasome Pharmaceuticals at 21 sites in United States.
Trial summary
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- HDV Insulin Lispro and Insulin LISPRO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2016to 15 Jun 2018
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 yrs. of age
- Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months
- Body Mass Index (BMI) ≤ 35 Kg/m2
- Basal insulin includes insulin Glargine or insulin Detemir
- Patient should be using bolus insulin defined as 2 to 4 doses of regular human insulin or rapid-acting analog at meals
- HbA1c ≥ 7.0% and ≤ 10.5%
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- Fasting C-peptide ≤ 0.5 pmol/mL
- Willingness to adhere to protocol and perform all required tests
- Willing and able to review and sign the Informed Consent Form.
- If child bearing age, must use acceptable form of birth control (ligation, 2 forms of birth control)
- Willing to wear CGM devices and complete diaries.
Who cannot join
- Total daily insulin dose ≥ 1.5 IU/kg/day.
- History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that effect HbA1c measurements
- Evidence of serious complications of diabetes (eg, Symptomatic autonomic neuropathy)
- Patients who are selected to but are unwilling or unable to participate in the MRI evaluation subset. (These patients may still participate in the non-MRI subset).
- Significant cardiovascular dysfunction or history within 12 months of Screening, eg, congestive heart failure (New York Heart Association Class III or IV), or clinically significant arrhythmia, myocardial infarction, cardiac surgery; history of valvular heart disease including mild or greater aortic insufficiency, or moderate or greater mitral insufficiency; recurrent syncope, transient ischemic attacks, or cerebrovascular accident
- Impaired liver function with elevated enzymes > 50% above the normal range at Screening. Patients with elevated liver enzymes may have the test repeated only at Visit 2 on a case-by-case basis at the request of the PI.
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- Creatinine level > 2 mg/dL for men, and > 1.8 mg/dL for women at Screening.
- Patient on low carbohydrate diet, such as Atkins Diet
- History of Adrenal supplementation within 3 years of Screening.
- History of unawareness or SEVERE recurrent hypoglycemia, defined as a patient who is unaware of symptoms of hypoglycemia, or due to autonomic dysfunction, has no inherent warnings of hypoglycemia, and therefore requires outside assistance to rectify any episodes of hypoglycemia
- Patients treated with systemic corticosteroids (Sporadic use of inhaled, intraarticular, and topical corticosteroids is not considered systemic).
- Patients with triglyceride levels ≥500 mg/dL at Screening.
- Patients with a history of cancer within the past 5 years, excluding basal or squamous cell carcinoma localized to the skin.
- Epilepsy or other physical or medical conditions which could result in non-compliance with the study.
- Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study
- Unwilling to discontinue use of an insulin pump for the duration of the study.
- Women who are pregnant, nursing, or planning to become pregnant during the course of the study.
- Patients on NPH as their basal insulin.
- Positive history of hepatitis A (within 12 months of Screening), or a positive history of hepatitis B, hepatitis C, or HIV at Screening.
- History of drug addiction and/or alcohol abuse within 12 months of Screening.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Hope & Wellness Clinical Trials, Inc.
Corona, California, 92882
Creekside Endocrine Associates, PC
Denver, Colorado, 80209
Associates in Endocrinology
Elgin, Illinois, 60124
Desert Endocrinology Clinical Research Center
Henderson, Nevada, 89052
Endocrine and Psychiatry Center
Houston, Texas, 77095
Rocky Mountain Diabetes & Osteoporosis Center, PA
Idaho Falls, Idaho, 83404
National Research Institute
Los Angeles, California, 90057
Advanced Pharma CR, LLC
Miami, Florida, 33147
LION Research
Norman, Oklahoma, 73072
California Medical Research Associates Inc.
Northridge, California, 91324
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Progressive Medical Research
Port Orange, Florida, 32127
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Bay Area Clinical Research
San Carlos, California, 94070
Mills-Peninsula Health Services
San Mateo, California, 94401
SUNY Upstate Medical University
Syracuse, New York, 13210
Orange County Research Center
Tustin, California, 92780
University of Massachusetts Memorial Hospital
Worcester, Massachusetts, 01655
About this study
Official title: Phase 2b, Multicenter, Randomized, Double Blind, Titration Trial for Efficacy and Safety of HDV Insulin Lispro in Combination With a Basal Insulin Versus Insulin Lispro in Combination With a Basal Insulin in Patients With Type 1 Diabetes
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c).
Read the detailed description
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir.
SCREENING (Visit 1, Week -4 to -1) Patients will arrive for Screening following an 8 hour fast. During Screening, patients will sign the informed consent form, be reviewed for inclusion/exclusion, and provide medical history, concomitant medications, and demographics. They will have a brief physical exam and provide vital signs. Safety hematology/chemistry/urinalysis (with liver enzymes) will include infectious serology, and serum pregnancy test for women of childbearing potential. An ECG will be performed and patients will provide samples for HbA1c determination.
Patients taking lispro/glargine or lispro/detemir at the time of Screening and who meet all eligibility criteria will proceed to Visit 2 (Week -1).
TREATMENT PERIOD Visit 1a (Week -2) will be required only if a patient must convert to lispro prior to Visit 3 (Week 0, randomization). Patients taking non-lispro/glargine or non-lispro/detemir or using an insulin pump will be converted to lispro/glargine or lispro/detemir (respectively) using equivalent insulin units, then proceed to Visit 2 (Week -1) after 1 week on the new regimen. At Visit 2 (Week -1), patients will receive the CGM and be trained on its use. Patients will also have their first Mixed Meal Tolerance Test (MMTT) during Visit 2 (Week -1) accompanied by monitoring of blood ketones pre- and post-ingestion. CGM and MMTT will be repeated at Visits 9 (Week 12) and 14 (Week 25). A diary, glucose meter, and supplies will also be provided at Visit 2 (Week -1). Patients will be instructed on how to perform self-monitored blood glucose measurements (SMBG). During Visit 3 (Week 0), eligible patients will be randomized by IWRS to either treatment arm (Test Group or Control Group) and baseline data will be collected. All visits will include progress reviews and safety procedures. Safety hematology/chemistry/ urinalysis at Visits 2 (Week -1), 10 (Week 13), 14 (Week 25) and 16 (Week 27) will include liver enzymes. At Visits 6 (Week 5) and 12 (Week 19), liver enzymes will be the only chemistry safety tests performed. The only chemistry safety tests performed at Visits 2 (Week -1), 9 (Week 12), and 14 (Week 25) will be blood ketones; these will be measured at baseline and 3 hours after the MMTT. HbA1c will be measured at Visits 3 (Week 0), 4 (Week 1), 7 (Week 7), 10 (Week 13), 12 (Week 19), and 15 (Week 26). Fasting blood glucose will be measured at Visits 3 (Week 0), 10 (Week 13), and 15 (Week 26). An in-clinic urine pregnancy test will be performed at all visits for women of childbearing potential. MRI will be performed at Visits 3 (Week 0) and 14 (Week 25) for approximately 20% of patients in each treatment arm. MRI may also be performed on a case-by-case basis in the event of abnormal liver enzyme results. Patients will receive weekly telephone calls from the PI or a designee to discuss insulin dosing and titration.
FOLLOW-UP Visit 16 (Week 27) is a safety follow-up visit which will include a physical exam. Safety hematology/chemistry/ urinalysis (including liver enzymes) will include a urine pregnancy test for women of childbearing potential.
Concomitant medications, vital signs, and adverse events will be recorded throughout the entire study period.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- HDV Insulin Lispro, Insulin LISPRO
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDV Insulin LisproDrug
Also called HDV Humalog
HDV Insulin Lispro: ~1% of the Insulin Lispro is bound to HDV (Hepatocyte Directed Vesicle)
Insulin LISPRODrug
Also called Humalog
Insulin Lispro: no bound insulin
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | HDV Insulin Lispro subcutaneous, pre-prandial dosing, 26 week treatment period Receives: Drug: HDV Insulin Lispro |
| Control Group | Active comparator | Insulin Lispro subcutaneous, Pre-prandial dosing, 26 week treatment period Receives: Drug: Insulin LISPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c from Week 0 to Week 13, from Week 0 to Week 26, and from Week 13 to Week 26
Measured: 26 weeks
Secondary outcomes (6)
Change in fasting blood glucose glucose levels
Difference in fasting blood glucose levels Mean Mixed Tolerance Test AUC,
Measured: 26 weeks
Hypoglycemia occurrences by category: Severe, Documented Symptomatic, and Asymptomatic Hypoglycemia
Comparison of frequency and severity of hypoglycemia
Measured: 26 weeks
Number of Patients with Adverse Events
- To demonstrate the safety of HDV insulin lispro over 26 weeks of administration.
Measured: 26 weeks
Change in total insulin usage
- Comparison of basal and bolus insulin doses as a mean of 3 days of use at Week 0 and at 13 and 26 weeks, and comparison of total bolus insulin dosing at end of run-in phase to the end of the 13 week treatment period, and from the 13 week treatment period to the 26 week treatment period.
Measured: 26 weeks
Change in Body Weight
Comparison of change in body weight (in Kilograms) from baseline through week 26.
Measured: 26 weeks
Mean Mixed Meal Tolerance Test
Comparison of mean mixed meal tolerance test (MMTT) (AUC0-120) from Week 0 (baseline) to Week 13, from Week 0 (baseline) to Week 26, and from Week 13 to Week 26
Measured: 13 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion28 Apr 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diasome Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- David Klonoff, MD, Principal investigator, Mills-Peninsula Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794155
- Sponsor's protocol ID
- DP 01-2015-01
- Acronym
- ISLE-1
- Status last verified
- Jan 2017
- First submitted
- 16 May 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klonoff D, Bode B, Cohen N, Penn M, Geho WB, Muchmore DB. Divergent Hypoglycemic Effects of Hepatic-Directed Prandial Insulin: A 6-Month Phase 2b Study in Type 1 Diabetes. Diabetes Care. 2019 Nov;42(11):2154-2157. doi: 10.2337/dc19-0152. Epub 2019 Sep 24.
PubMed 31551249
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b, Multicenter, Randomized, Double Blind, Titration Trial for Efficacy and Safety of HDV Insulin Lispro in Combination With a Basal Insulin Versus Insulin Lispro in Combination With a Basal Insulin in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02794155
- Acronym / sponsor ID
- ISLE-1 / DP 01-2015-01
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Diasome PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- Jun 2016
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 8 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.
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c).
Detailed description
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir.
SCREENING (Visit 1, Week -4 to -1) Patients will arrive for Screening following an 8 hour fast. During Screening, patients will sign the informed consent form, be reviewed for inclusion/exclusion, and provide medical history, concomitant medications, and demographics. They will have a brief physical exam and provide vital signs. Safety hematology/chemistry/urinalysis (with liver enzymes) will include infectious serology, and serum pregnancy test for women of childbearing potential. An ECG will be performed and patients will provide samples for HbA1c determination.
Patients taking lispro/glargine or lispro/detemir at the time of Screening and who meet all eligibility criteria will proceed to Visit 2 (Week -1).
TREATMENT PERIOD Visit 1a (Week -2) will be required only if a patient must convert to lispro prior to Visit 3 (Week 0, randomization). Patients taking non-lispro/glargine or non-lispro/detemir or using an insulin pump will be converted to lispro/glargine or lispro/detemir (respectively) using equivalent insulin units, then proceed to Visit 2 (Week -1) after 1 week on the new regimen. At Visit 2 (Week -1), patients will receive the CGM and be trained on its use. Patients will also have their first Mixed Meal Tolerance Test (MMTT) during Visit 2 (Week -1) accompanied by monitoring of blood ketones pre- and post-ingestion. CGM and MMTT will be repeated at Visits 9 (Week 12) and 14 (Week 25). A diary, glucose meter, and supplies will also be provided at Visit 2 (Week -1). Patients will be instructed on how to perform self-monitored blood glucose measurements (SMBG). During Visit 3 (Week 0), eligible patients will be randomized by IWRS to either treatment arm (Test Group or Control Group) and baseline data will be collected. All visits will include progress reviews and safety procedures. Safety hematology/chemistry/ urinalysis at Visits 2 (Week -1), 10 (Week 13), 14 (Week 25) and 16 (Week 27) will include liver enzymes. At Visits 6 (Week 5) and 12 (Week 19), liver enzymes will be the only chemistry safety tests performed. The only chemistry safety tests performed at Visits 2 (Week -1), 9 (Week 12), and 14 (Week 25) will be blood ketones; these will be measured at baseline and 3 hours after the MMTT. HbA1c will be measured at Visits 3 (Week 0), 4 (Week 1), 7 (Week 7), 10 (Week 13), 12 (Week 19), and 15 (Week 26). Fasting blood glucose will be measured at Visits 3 (Week 0), 10 (Week 13), and 15 (Week 26). An in-clinic urine pregnancy test will be performed at all visits for women of childbearing potential. MRI will be performed at Visits 3 (Week 0) and 14 (Week 25) for approximately 20% of patients in each treatment arm. MRI may also be performed on a case-by-case basis in the event of abnormal liver enzyme results. Patients will receive weekly telephone calls from the PI or a designee to discuss insulin dosing and titration.
FOLLOW-UP Visit 16 (Week 27) is a safety follow-up visit which will include a physical exam. Safety hematology/chemistry/ urinalysis (including liver enzymes) will include a urine pregnancy test for women of childbearing potential.
Concomitant medications, vital signs, and adverse events will be recorded throughout the entire study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: HDV Insulin LisproHDV Insulin Lispro subcutaneous, pre-prandial dosing, 26 week treatment period |
| Control Group | Active comparator | Drug: Insulin LISPROInsulin Lispro subcutaneous, Pre-prandial dosing, 26 week treatment period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women ≥ 18 yrs. of age
- Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months
- Body Mass Index (BMI) ≤ 35 Kg/m2
- Basal insulin includes insulin Glargine or insulin Detemir
- Patient should be using bolus insulin defined as 2 to 4 doses of regular human insulin or rapid-acting analog at meals
Key exclusion criteria (20 listed)
- Total daily insulin dose ≥ 1.5 IU/kg/day.
- History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that effect HbA1c measurements
- Evidence of serious complications of diabetes (eg, Symptomatic autonomic neuropathy)
- Patients who are selected to but are unwilling or unable to participate in the MRI evaluation subset. (These patients may still participate in the non-MRI subset).
- Significant cardiovascular dysfunction or history within 12 months of Screening, eg, congestive heart failure (New York Heart Association Class III or IV), or clinically significant arrhythmia, myocardial infarction, cardiac surgery; history of valvular heart disease including mild or greater aortic insufficiency, or moderate or greater mitral insufficiency; recurrent syncope, transient ischemic attacks, or cerebrovascular accident
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 |
|---|---|---|
| HDV Insulin LisproAlso: HDV HumalogHDV Insulin Lispro: ~1% of the Insulin Lispro is bound to HDV (Hepatocyte Directed Vesicle) | Drug | Test Group |
| Insulin LISPROAlso: HumalogInsulin Lispro: no bound insulin | Drug | Control Group |
Primary outcome
Change in HbA1c
Time frame: 26 weeks
Change in HbA1c from Week 0 to Week 13, from Week 0 to Week 26, and from Week 13 to Week 26
6 secondary outcomes
Change in fasting blood glucose glucose levels
Time frame: 26 weeks
Hypoglycemia occurrences by category: Severe, Documented Symptomatic, and Asymptomatic Hypoglycemia
Time frame: 26 weeks
Number of Patients with Adverse Events
Time frame: 26 weeks
Change in total insulin usage
Time frame: 26 weeks
Change in Body Weight
Time frame: 26 weeks
Mean Mixed Meal Tolerance Test
Time frame: 13 and 26 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 31 Jul 2018.
- Derived from this study: PubMed 31551249Klonoff D, Bode B, Cohen N, Penn M, Geho WB, Muchmore DB. Divergent Hypoglycemic Effects of Hepatic-Directed Prandial Insulin: A 6-Month Phase 2b Study in Type 1 Diabetes. Diabetes Care. 2019 Nov;42(11):2154-2157. doi: 10.2337/dc19-0152. Epub 2019 Sep 24.
- 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.
David Klonoff, MD principal investigator
Mills-Peninsula Health Services
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDV Insulin Lispro and Insulin LISPRO in people with Type 1 Diabetes Mellitus, run by Diasome Pharmaceuticals at 21 sites 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 11 inclusion and 20 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in HbA1c (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794155, which also lists 1 linked publication.
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 31 Jul 2018.