Type 2 DiabetesNCT01089569
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
A study testing Exenatide and Insulin Glargine in people with Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.
Trial summary
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exenatide and Insulin Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female subjects ≥18 and ≤75 years of age
- Clinical diagnosis of type 2 diabetes
- Diabetes duration ≥ 1 year
- HbA1c ≥7.0%
- Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)
Who cannot join
- Previously treated with insulin or incretin-based therapy
- Treated with a thiazolidinedione within past 6 weeks
- Taken oral or injected prednisone or cortisone medications in the previous 30 days
- Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
- Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
- eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
Show all 13Show fewer
- ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)
- Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
- Currently pregnant or planning pregnancy during the study period
- Unable to follow the study protocol
- Unable to speak, read and write in English
- Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
- At the investigator's discretion for other medical or psychological reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.
Read the detailed description
The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.
An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.
- Conditions
- Type 2 Diabetes
- Being tested
- Exenatide, Insulin Glargine
- Keywords
- diabetes, continuous glucose monitoring, exenatide, insulin glargine
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Bydureon
5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
Insulin GlargineDrug
Also called Lantus
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Active comparator | 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study Receives: Drug: Exenatide |
| Insulin Glargine | Active comparator | .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results Receives: Drug: Insulin Glargine |
| Exenatide + Insulin Glargine | Active comparator | Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results Receives: Drug: Exenatide; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Change
Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination.
Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
Measured: baseline to final visit (32 weeks)
Secondary outcomes (6)
Change From Baseline in Incidence of Hypoglycemia (Frequency)
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (frequency)
Change from baseline was calculated as mean incidence rate at baseline minus mean incidence rate at final visit (32 weeks)
Measured: baseline to final visit (32 weeks)
Change From Baseline in Incidence of Hypoglycemia (Degree)
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (degree) Change from baseline was calculated as mean incidence percentage at baseline minus mean incidence percentage at final visit (32 weeks)
Measured: baseline to final visit (32 weeks)
Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves iii. Glucose stability (absolute hourly rate of change in median curve)
Change from baseline was calculated as mean absolute hourly rate of change in median curve at baseline minus rate at final visit (32 weeks). Mean absolute hourly rate of change in the smoothed median curve is calculated as delta subscript MC = (|p subscript 50 zero - p subscript 50 23|+Sum superscript 23 subscript i = 1| p subscript 50i - p subscript 50 i-1| over T.
i = hour of day p subscript 50i = smoothed 50th percentile value for ith hour of day T = total # of non-missing hourly smoothed percentiles
Measured: baseline to final visit (32 weeks)
Change From Baseline in CGM Glucose Variability
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- ii. Glucose variability (inter-quartile range)
IQR is the difference between the 75th and 25th percentiles. Change from baseline was calculated as IQR at baseline minus IQR value at final visit (32 weeks).
Measured: baseline to final visit (32 weeks)
Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) Change from baseline was calculated as area under the diurnal median curve at baseline minus AUC value at final visit (32 weeks).
AUC is calculated using modified rectangle method AUC = sum of superscript 23, subscript i=0 P subscript 50i I = hour of day P subscript 50i = smoother 50th percentile value for ith hour of day
Measured: baseline - final visit (32 weeks)
Change From Baseline in Weight Changes
Measure the changes in weight attributable to exenatide, insulin glargine and their combinations.
Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
Change from baseline was calculated as weight in pounds at baseline minus weight in pounds at final visit (32 weeks).
Measured: baseline - final visit (32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Sanofi
- Responsible party
- Sponsor
- Investigators
- Richard M Bergenstal, MD, Principal investigator, International Diabetes Center at Park NicolletRoger S Mazze, PhD, Principal investigator, International Diabetes Center at Park NicolletElinor S Strock, APRN, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089569
- Sponsor's protocol ID
- 03951-10-C
- Status last verified
- Oct 2013
- First submitted
- 17 Mar 2010
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293.
PubMed 18473688Mazze R, Strock E, Morgan B, Wesley D, Bergenstal R, Cuddihy R. Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profile analysis. Endocr Pract. 2009 May-Jun;15(4):326-34. doi: 10.4158/EP09046.ORR.
PubMed 19454385
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis
- ClinicalTrials.gov ID
- NCT01089569
- Acronym / sponsor ID
- 03951-10-C
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, continuous glucose monitoring, exenatide, insulin glargine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Sanofi
- Study start
- Apr 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.
Detailed description
The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.
An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Active comparator | Drug: Exenatide5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study |
| Insulin Glargine | Active comparator | Drug: Insulin Glargine.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results |
| Exenatide + Insulin Glargine | Active comparator | Drug: Exenatide, Drug: Insulin GlargineExenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study + Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects ≥18 and ≤75 years of age
- Clinical diagnosis of type 2 diabetes
- Diabetes duration ≥ 1 year
- HbA1c ≥7.0%
- Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)
Key exclusion criteria (13 listed)
- Previously treated with insulin or incretin-based therapy
- Treated with a thiazolidinedione within past 6 weeks
- Taken oral or injected prednisone or cortisone medications in the previous 30 days
- Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
- Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
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 |
|---|---|---|
| ExenatideAlso: Bydureon5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study | Drug | Exenatide, Exenatide + Insulin Glargine |
| Insulin GlargineAlso: Lantus.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results | Drug | Exenatide + Insulin Glargine, Insulin Glargine |
Primary outcome
HbA1c Change
Time frame: baseline to final visit (32 weeks)
Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination. Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
6 secondary outcomes
Change From Baseline in Incidence of Hypoglycemia (Frequency)
Time frame: baseline to final visit (32 weeks)
Change From Baseline in Incidence of Hypoglycemia (Degree)
Time frame: baseline to final visit (32 weeks)
Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)
Time frame: baseline to final visit (32 weeks)
Change From Baseline in CGM Glucose Variability
Time frame: baseline to final visit (32 weeks)
Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)
Time frame: baseline - final visit (32 weeks)
Change From Baseline in Weight Changes
Time frame: baseline - final visit (32 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18473688Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293.
- Background: PubMed 19454385Mazze R, Strock E, Morgan B, Wesley D, Bergenstal R, Cuddihy R. Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profile analysis. Endocr Pract. 2009 May-Jun;15(4):326-34. doi: 10.4158/EP09046.ORR.
- 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.
Richard M Bergenstal, MD principal investigator
International Diabetes Center at Park Nicollet
Roger S Mazze, PhD principal investigator
International Diabetes Center at Park Nicollet
Elinor S Strock, APRN principal investigator
International Diabetes Center at Park Nicollet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide and Insulin Glargine in people with Type 2 Diabetes, run by HealthPartners Institute 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 5 inclusion and 13 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 23 May 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. 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?
Yes. Results are posted in the registry (first posted 23 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HbA1c Change (time frame: baseline to final visit (32 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 NCT01089569, which also lists 2 linked publications.
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 23 May 2017.