Type 2 DiabetesNCT02443922
Dynamic Responsiveness of Insulin Secretory Parameters To Sitagliptin and Glimeperide Administration in Type 2 DM
A study testing Glimepiride, Sitagliptin and Metformin in people with Type 2 Diabetes, run by Foundation for the National Institutes of Health.
Trial summary
A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Glimepiride, Sitagliptin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent and comply with all study requirements
- Overweight and obese men and women. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history (with the exception of glucose, see below), full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
- T2D diagnosis by ADA criteria 2011
- Glucose Parameters:
- Fasting glucose 126-270 mg/dL
- HbA1c 7.0%-10.0%
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- Diabetes medications allowed: metformin only: stable dose (8 weeks or longer) and 500-2000 mg/day;
- Estimated creatinine clearance, by Cockcroft-Gault, >60 cc/min
- No washout of medications allowed
- Women of child-bearing potential are allowed (but must agree to use non-hormonal contraception and not plan to become pregnant for the duration of the study). Must agree to maintain the same contraceptive measures throughout the study. Acceptable contraceptive methods for female subjects of childbearing potential include one of the following:
- Abstinence
- One (1) of the following methods:
- Tubal ligation
- Copper-containing intrauterine device (IUD)
- Condom AND spermicidal foam/gel/film/cream/suppository
- Male partner who has had a vasectomy for at least 6 months.
- It is required that all male subjects use an acceptable method of contraception (as outlined below), starting from the first dose of study medication and continuing for at least 28 days after the last dose of study drug:
- Abstinence
- A condom AND one of the following:
- Vasectomy for more than 6 months
- Female partner who meets one of the following conditions:
- Has had a tubal ligation, hysterectomy, or bilateral oophorectomy; or
- Is post menopausal (menopause is defined as over the age of 60 years, or between 45 and 60 years being amenorrheic for at least 2 years with plasma (FSH) level > 30 UI/L) or
- Or for female partners of the male participants, in addition to hysterectomy, oophorectorectomy, or post-menopausal status, that the use of a spermicidal gel or foam will constitute adequate protection in conjunction with use of a condom by the male.
- BMI 27-40; stable weight (less than 3% change in past 3 months)
- Age Range: 30-65
- Other conditions may be allowed, if medically stable and controlled for at least four weeks within clinically acceptable limits, including: hypertension, dyslipidemia, osteoarthritis, osteoporosis
- Smokers allowed, but must be able to participate on inpatient stay and not smoke
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, neoplastic, or allergic or clinical findings at Screening (seasonal allergies allowed).
- Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).
- Use of unacceptable medications (see Appendix A)
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
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- Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
- 12 lead ECG demonstrating QTc >450 msec at Screening for males, 470 msec for females. If QTc exceeds 450/470 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. An ECG with evidence for possible old myocardial infarction will need to have prior ECGs to document stability of finding.
- Supine blood pressure >=140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement. If elevated, confirm by a single repeat, following at least 10 minutes of rest.
- Screening serum alanine transaminase (ALT) or serum aspartate transaminase (AST) greater than 2X the upper limit of the laboratory reference range.
- Elevated fasting triglycerides at screening (>500 mg/dL), confirmed by a single repeat if deemed necessary.
- Pregnant or nursing females; inability to use effective contraception.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- Participation in a clinical biomedical research study within prior two months may be excluded, depending on study type and details.
- History of sensitivity to heparin or heparin-induced thrombocytopenia, if utilized by the site for blood draws.
- Unwilling or unable to comply with directions and procedures described in this protocol.
- Subject is the Investigator or a sub-Investigator, research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
About this study
Official title: Dynamic Responsiveness of Insulin Secretory Parameters to Sitagliptin and Glimeperide Administration in Subjects With Type 2 Diabetes Mellitus: An Open Label Study
A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus.
Read the detailed description
A three-year observational study to standardize the meal tolerance and maximal stimulation tests for measuring beta cell function in the clinical setting. It also aims to improve methods for the early prediction of the long-term response to an intervention and for identification of patients at risk for rapid beta cell function deterioration, thereby enabling future clinical studies that examine diabetes progression.
The objective of this protocol is to establish the dynamic responsivity of the methods to treatment with glimerpiride or sitagliptin.
- Conditions
- Type 2 Diabetes
- Being tested
- Glimepiride, Sitagliptin, Metformin
- Keywords
- type 2 diabetes, beta cell function, meal tolerance test (MTT), maximal stimulation test (MaxStim), method standardization, insulin secretion, prediabetes, insulin sensitivity, glimepiride, sitagliptin, metformin
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlimepirideDrug
Also called Amaryl
Glimepiride 2mg qam
SitagliptinDrug
Also called Januvia
Sitagliptin 100mg qam
MetforminDrug
Also called Fortamet, Glucophage, Glumetza, Riomet
Metformin as prescribed
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride | Experimental | Glimepiride 2mg qam Receives: Drug: Glimepiride; Drug: Metformin |
| Sitagliptin | Experimental | Sitagliptin 100mg qam Receives: Drug: Sitagliptin; Drug: Metformin |
| Metformin | Active comparator | Metformin as prescribed Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta Cell Function as measured by the mixed meal tolerance test in response to two therapies for type 2 diabetes mellitus
Measured: Up to 6 weeks
Beta Cell Function as measured by the arginine stimulation test in response to two therapies for type 2 diabetes mellitus
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for the National Institutes of Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation, Amylin Pharmaceuticals, LLC., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Merck Sharp & Dohme LLC, Novartis, Pfizer, Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443922
- Sponsor's protocol ID
- Beta Cell - Protocol 2
- Status last verified
- May 2015
- First submitted
- 8 May 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Responsiveness of Insulin Secretory Parameters to Sitagliptin and Glimeperide Administration in Subjects With Type 2 Diabetes Mellitus: An Open Label Study
- ClinicalTrials.gov ID
- NCT02443922
- Acronym / sponsor ID
- Beta Cell - Protocol 2
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, beta cell function, meal tolerance test (MTT), maximal stimulation test (MaxStim), method standardization, insulin secretion, prediabetes, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Foundation for the National Institutes of HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation, Amylin Pharmaceuticals, LLC., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Merck Sharp & Dohme LLC, Novartis, Pfizer, Takeda
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 May 2015 (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.
A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus.
Detailed description
A three-year observational study to standardize the meal tolerance and maximal stimulation tests for measuring beta cell function in the clinical setting. It also aims to improve methods for the early prediction of the long-term response to an intervention and for identification of patients at risk for rapid beta cell function deterioration, thereby enabling future clinical studies that examine diabetes progression.
The objective of this protocol is to establish the dynamic responsivity of the methods to treatment with glimerpiride or sitagliptin.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glimepiride | Experimental | Drug: Glimepiride, Drug: MetforminGlimepiride 2mg qam |
| Sitagliptin | Experimental | Drug: Sitagliptin, Drug: MetforminSitagliptin 100mg qam |
| Metformin | Active comparator | Drug: MetforminMetformin as prescribed |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Ability to give informed consent and comply with all study requirements
- Overweight and obese men and women. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history (with the exception of glucose, see below), full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
- T2D diagnosis by ADA criteria 2011
- Glucose Parameters:
- Diabetes medications allowed: metformin only: stable dose (8 weeks or longer) and 500-2000 mg/day;
Key exclusion criteria (18 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, neoplastic, or allergic or clinical findings at Screening (seasonal allergies allowed).
- Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).
- Use of unacceptable medications (see Appendix A)
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
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 |
|---|---|---|
| GlimepirideAlso: AmarylGlimepiride 2mg qam | Drug | Glimepiride |
| SitagliptinAlso: JanuviaSitagliptin 100mg qam | Drug | Sitagliptin |
| MetforminAlso: Fortamet, Glucophage, Glumetza, RiometMetformin as prescribed | Drug | Glimepiride, Metformin, Sitagliptin |
Primary outcome
Beta Cell Function as measured by the mixed meal tolerance test in response to two therapies for type 2 diabetes mellitus
Time frame: Up to 6 weeks
Beta Cell Function as measured by the arginine stimulation test in response to two therapies for type 2 diabetes mellitus
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Glimepiride, Sitagliptin and Metformin in people with Type 2 Diabetes, run by Foundation for the National Institutes of Health.
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 28 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Beta Cell Function as measured by the mixed meal tolerance test in response to two therapies for type 2 diabetes mellitus (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. 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 14 May 2015.