Diabetes Mellitus Type 2Phase 4NCT01547104
Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Linagliptin and Glimepiride in people with Diabetes Mellitus Type 2, run by Marcus Borchert at 1 site in Germany.
Trial summary
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Linagliptin and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Oct 2012
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 2
- HbA1c > 6.5% - ≤ 8.5%
- HbA1c > 7.0% - ≤ 8.5% for those patients with a significant cardiovascular history
- Treatment with metformin at a maximum tolerated dose
- Age 45 - 75 years (inclusively)
- Patient consents that his/her family physician/diabetologist will be informed of trial participation.
Who cannot join
- Pretreatment with PPAR gamma agonists within the last three months
- History of type 1 diabetes
- Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg)
- Acute infections
- Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
Show all 29Show fewer
- Treatment with any other investigational drug within 3 months before trial entry.
- Progressive fatal disease
- History of drug or alcohol abuse in the past 2 years
- State after kidney transplantation
- Serum potassium > 5.5 mmol/L
- Pregnancy or breast feeding
- Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomized partner.
- Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 30 days
- Any elective surgery during study participation
- Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit
- History of pancreatitis
- History of dehydration, pre-coma diabeticum or diabetic ketoacidosis
- Acute or scheduled investigation with iodine containing radiopaque material
- Uncontrolled unstable angina pectoris
- History of pericarditis, myocarditis, endocarditis
- Recent pulmonary embolism
- Hemodynamic relevant aortic stenosis
- Aortic aneurysm
- Regular use of NSAID's (no acute use of NSAID within 48 hours before V2,V4,V5)
- Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
- History of respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (Creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men ), neurological, psychiatric and/or hematological disease as judged by the investigator
- Lactose intolerance
- Intake of Coumarin or coumarin derived compounds such as phenprocoumon (Marcumar) or warfarin (Coumadin, Warfant)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
ikfe GmbH
Mainz, Rhineland-Palatinate, 55116
Thomas Forst, MD, PhD, + 49 6131 57636 ext. 16, ThomasF@ikfe.de
Daniela Sachsenheimer, MD, + 49 6131 57636 ext. 46, DanielaS@ikfe.de
About this study
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.
Read the detailed description
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.
This mechanistic phase IV study has a prospective, comparative, open, randomized, two arm and exploratory design. Overall 40 Patients will be randomized to two treatment arms both receiving Metformin at a maximally tolerated dose. In addition to that both treatment groups will receive either an individually titrated dose of Glimepiride or 5mg once daily of Linagliptin. Subsequent to a standardized meal, several parameters reflecting beta cell function, metabolism and oxidative stress will be evaluated.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Linagliptin, Glimepiride
- 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.
LinagliptinDrug
Linagliptin dosed 5 mg as add on therapy to an existing metformin therapy
GlimepirideDrug
Also called Glimepirid-ratiopharm
Glimepiride 1-4mg (individually dosed) as add on therapy to an existing metformin therapy
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride-ratiopharm | Active comparator | Glimepiride (1-4mg) as add on therapy Receives: Drug: Glimepiride |
| Trajenta | Experimental | Linagliptin 5 mg as add on therapy Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial increase in intact Proinsulin levels (Peak, AUC)
Measured: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Postprandial Proinsulin/Insulin Ratio
Measured: after 12 weeks treatment
Fasting intact Proinsulin levels
Measured: after 12 weeks treatment
Fasting Proinsulin/Insulin Ratio
Measured: after 12 weeks treatment
Fasting Blood Glucose
Measured: after 12 weeks treatment
Postprandial Blood Glucose Excursions (Peak; AUC)
Measured: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Fasting Lipids
Measured: after 12 weeks treatment
Postprandial Lipids
Measured: after 12 weeks treatment
Fasting Erythrocyte Flexibility
Measured: after 12 weeks treatment
Postprandial Erythrocyte Flexibility
Measured: after 12 weeks treatment
Fasting GLP-1 levels
Measured: after 12 weeks treatment
Postprandial GLP-1 levels
Measured: after 12 weeks treatment
Fasting cGMP
Measured: after 12 weeks treatment
Postprandial cGMP
Measured: after 12 weeks treatment
Fasting Calcitonin
Measured: after 12 weeks treatment
Fasting PAI-1 levels
Measured: after 12 weeks treatment
Postprandial PAI-1 levels
Measured: after 12 weeks treatment
Fasting ADMA levels
Measured: after 12 weeks treatment
Postprandial ADMA levels
Measured: after 12 weeks treatment
Fasting Malonyldialdehyd
Measured: after 12 weeks treatment
fasting oxidatively modified nucleosides 8-oxodG and 8-oxoGuo
Measured: after 12 weeks treatment
Secondary outcomes (2)
Hypoglycemic events
Measured: after 12 weeks treatment
Body Weight
Measured: after 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcus Borchert
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ikfe-CRO GmbH, Boehringer Ingelheim
- Responsible party
- Sponsor-investigator, Marcus Borchert, ikfe-CRO GmbH
- Investigators
- Thomas Forst, MD, PhD, Principal investigator, Ikfe GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547104
- Sponsor's protocol ID
- ikfe-Lina-002
- Other IDs
- 2012-000179-17
- Status last verified
- Apr 2012
- First submitted
- 21 Feb 2012
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01547104
- Acronym / sponsor ID
- ikfe-Lina-002
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marcus BorchertIndustry (pharma, biotech, devices)
- Collaborators
- ikfe-CRO GmbH, Boehringer Ingelheim
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 7 Mar 2012 (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.
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.
Detailed description
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.
This mechanistic phase IV study has a prospective, comparative, open, randomized, two arm and exploratory design. Overall 40 Patients will be randomized to two treatment arms both receiving Metformin at a maximally tolerated dose. In addition to that both treatment groups will receive either an individually titrated dose of Glimepiride or 5mg once daily of Linagliptin. Subsequent to a standardized meal, several parameters reflecting beta cell function, metabolism and oxidative stress will be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glimepiride-ratiopharm | Active comparator | Drug: GlimepirideGlimepiride (1-4mg) as add on therapy |
| Trajenta | Experimental | Drug: LinagliptinLinagliptin 5 mg as add on therapy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus type 2
- HbA1c > 6.5% - ≤ 8.5%
- HbA1c > 7.0% - ≤ 8.5% for those patients with a significant cardiovascular history
- Treatment with metformin at a maximum tolerated dose
- Age 45 - 75 years (inclusively)
Key exclusion criteria (29 listed)
- Pretreatment with PPAR gamma agonists within the last three months
- History of type 1 diabetes
- Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg)
- Acute infections
- Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
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 |
|---|---|---|
| LinagliptinLinagliptin dosed 5 mg as add on therapy to an existing metformin therapy | Drug | Trajenta |
| GlimepirideAlso: Glimepirid-ratiopharmGlimepiride 1-4mg (individually dosed) as add on therapy to an existing metformin therapy | Drug | Glimepiride-ratiopharm |
Primary outcome
Postprandial increase in intact Proinsulin levels (Peak, AUC)
Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Postprandial Proinsulin/Insulin Ratio
Time frame: after 12 weeks treatment
Fasting intact Proinsulin levels
Time frame: after 12 weeks treatment
Fasting Proinsulin/Insulin Ratio
Time frame: after 12 weeks treatment
Fasting Blood Glucose
Time frame: after 12 weeks treatment
Postprandial Blood Glucose Excursions (Peak; AUC)
Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Fasting Lipids
Time frame: after 12 weeks treatment
Postprandial Lipids
Time frame: after 12 weeks treatment
Fasting Erythrocyte Flexibility
Time frame: after 12 weeks treatment
Postprandial Erythrocyte Flexibility
Time frame: after 12 weeks treatment
Fasting GLP-1 levels
Time frame: after 12 weeks treatment
Postprandial GLP-1 levels
Time frame: after 12 weeks treatment
Fasting cGMP
Time frame: after 12 weeks treatment
Postprandial cGMP
Time frame: after 12 weeks treatment
Fasting Calcitonin
Time frame: after 12 weeks treatment
Fasting PAI-1 levels
Time frame: after 12 weeks treatment
Postprandial PAI-1 levels
Time frame: after 12 weeks treatment
Fasting ADMA levels
Time frame: after 12 weeks treatment
Postprandial ADMA levels
Time frame: after 12 weeks treatment
Fasting Malonyldialdehyd
Time frame: after 12 weeks treatment
fasting oxidatively modified nucleosides 8-oxodG and 8-oxoGuo
Time frame: after 12 weeks treatment
2 secondary outcomes
Hypoglycemic events
Time frame: after 12 weeks treatment
Body Weight
Time frame: after 12 weeks treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
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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.
Thomas Forst, MD, PhD principal investigator
Ikfe GmbH
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 Linagliptin and Glimepiride in people with Diabetes Mellitus Type 2, run by Marcus Borchert 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 29 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 11 Apr 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Forst, MD, PhD (+ 49 6131 57636 ext. 16, ThomasF@ikfe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial increase in intact Proinsulin levels (Peak, AUC) (time frame: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment). The study lists 21 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 11 Apr 2012.