Type 2 DiabetesPhase 1NCT00971659
Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes
A Phase 1 study testing insulin glargine + exenatide + preexisting metformin, insulin glargine + sitagliptin + preexisting metformin and insulin glargine + preexisting metformin in people with Type 2 Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- insulin glargine + exenatide + preexisting metformin, insulin glargine + sitagliptin + preexisting metformin and insulin glargine + preexisting metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Nov 2008
- Phase
- Phase 1
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female subjects aged between 35 and 70 years, inclusive
- type 2 diabetes with duration >6 months and <10 years
- for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
- HbA1c >=7.0% and <=10.0%
- if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
- written informed consent
Who cannot join
- history or presence of cancer or any clinically relevant diseases
- chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months
- recurrent hypoglycemia
- abnormal lab tests at screening (ALAT and/or ASAT >=3 times ULN), creatinine >1.6 mg/dL in males and >1.4 mg/dL in females
- clinically relevant ECG findings at screening
- treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
- treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months
- any systemic or topical treatment with drugs known to influence glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily
This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.
Read the detailed description
Due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. Preexisting metformin was continued, sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ADA treatment goals (HbA1c < 7.0%) at the end of treatment, on fasting lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed. The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the site and twice weekly telephone contacts.
- Conditions
- Type 2 Diabetes
- Being tested
- insulin glargine + exenatide + preexisting metformin, insulin glargine + sitagliptin + preexisting metformin, insulin glargine + preexisting metformin
- Keywords
- type 2 diabetes
- 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.
insulin glargine + exenatide + preexisting metforminDrug
Also called Lantus, Byetta
insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin
insulin glargine + sitagliptin + preexisting metforminDrug
Also called Lantus, Januvia
insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin
insulin glargine + preexisting metforminDrug
Also called Lantus
insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin
| Study group | Role | What they receive |
|---|---|---|
| insulin glargine + exenatide + metformin | Experimental | Not described Receives: Drug: insulin glargine + exenatide + preexisting metformin |
| Insulin glargine + sitagliptin + metformin | Experimental | Not described Receives: Drug: insulin glargine + sitagliptin + preexisting metformin |
| insulin glargine + metformin | Active comparator | Not described Receives: Drug: insulin glargine + preexisting metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast
Measured: after 4 weeks of treatment
Secondary outcomes (1)
mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes
Measured: after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionNov 2008
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 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Investigators
- Sabine Arnolds, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971659
- Sponsor's protocol ID
- 49/0316-Adjunct
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Arnolds S, Dellweg S, Clair J, Dain MP, Nauck MA, Rave K, Kapitza C. Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study. Diabetes Care. 2010 Jul;33(7):1509-15. doi: 10.2337/dc09-2191. Epub 2010 Mar 31.
PubMed 20357372
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily
- ClinicalTrials.gov ID
- NCT00971659
- Acronym / sponsor ID
- 49/0316-Adjunct
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Sep 2009 (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 study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.
Detailed description
Due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. Preexisting metformin was continued, sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ADA treatment goals (HbA1c < 7.0%) at the end of treatment, on fasting lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed. The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the site and twice weekly telephone contacts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| insulin glargine + exenatide + metformin | Experimental | Drug: insulin glargine + exenatide + preexisting metformin |
| Insulin glargine + sitagliptin + metformin | Experimental | Drug: insulin glargine + sitagliptin + preexisting metformin |
| insulin glargine + metformin | Active comparator | Drug: insulin glargine + preexisting metformin |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female subjects aged between 35 and 70 years, inclusive
- type 2 diabetes with duration >6 months and <10 years
- for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
- HbA1c >=7.0% and <=10.0%
- if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
Key exclusion criteria (8 listed)
- history or presence of cancer or any clinically relevant diseases
- chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months
- recurrent hypoglycemia
- abnormal lab tests at screening (ALAT and/or ASAT >=3 times ULN), creatinine >1.6 mg/dL in males and >1.4 mg/dL in females
- clinically relevant ECG findings at 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 |
|---|---|---|
| insulin glargine + exenatide + preexisting metforminAlso: Lantus, Byettainsulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin | Drug | insulin glargine + exenatide + metformin |
| insulin glargine + sitagliptin + preexisting metforminAlso: Lantus, Januviainsulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin | Drug | Insulin glargine + sitagliptin + metformin |
| insulin glargine + preexisting metforminAlso: Lantusinsulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin | Drug | insulin glargine + metformin |
Primary outcome
the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast
Time frame: after 4 weeks of treatment
1 secondary outcome
mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes
Time frame: after 4 weeks of treatment
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 4 Sep 2009.
- Derived from this study: PubMed 20357372Arnolds S, Dellweg S, Clair J, Dain MP, Nauck MA, Rave K, Kapitza C. Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study. Diabetes Care. 2010 Jul;33(7):1509-15. doi: 10.2337/dc09-2191. Epub 2010 Mar 31.
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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.
Sabine Arnolds, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing insulin glargine + exenatide + preexisting metformin, insulin glargine + sitagliptin + preexisting metformin and insulin glargine + preexisting metformin in people with Type 2 Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
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 8 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 4 Sep 2009. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast (time frame: after 4 weeks of treatment). 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 NCT00971659, 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 4 Sep 2009.