Type 2 Diabetic PatientsPhase 4NCT00941148
Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin
A Phase 4 study testing Insulin Glargin, NPH insulin and Insulin detemir in people with Type 2 Diabetic Patients and Insufficient Metabolic Control, run by ikfe-CRO GmbH at 1 site in Germany.
Trial summary
The aim of the study is to show that treatment with Glargine will lead to an improvement in beta cell function especially within times of maximal beta cell stress occurring after a meal. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetic Patients, Insufficient Metabolic Control, OAD Treatment
- What is being tested?
- Insulin Glargin, NPH insulin and Insulin detemir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Mar 2009
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes mellitus according to the ADA criteria
- HbA1c between 6.5% and 8.5%
- Individually optimized combination therapy with metformin in combination with sulfonylurea in a stable dosage within the last 3 months
- Age between 40 and 75 years
- Fasting intact proinsulin level > 7 pmol/Land < 20 pmol/Lat screening
Who cannot join
- Type 1 Diabetes mellitus
- Pre-Treatment with insulin within the last 3 months prior to screening
- Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening
- Major micro- or macrovascular complications as judged by the investigator
- BMI > 40 kg/m²
- Hypokalemia (K < 3.5 mmol /L)
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- History of drug or alcohol abuse
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dL in women and > 1.7 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- Pregnancy or breast feeding
- Sexually active women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Insulin (I.)Glargine Compared to NPH I. and to I. Detemir in Combination With Metformin on Prandial ß-cell Function and Overall Metabolic Control in Type 2 Diabetic Patients With Insufficient Metabolic Control During OAD Treatment
The aim of the study is to show that treatment with Glargine will lead to an improvement in beta cell function especially within times of maximal beta cell stress occurring after a meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will be performed and the postprandial secretion of intact proinsulin levels will be measured. These measurements will be performed with patients treated in combination with metformin and insulin glargine versus metformin plus NPH insulin (within the core study) and if significant difference is observed, with a third treatment arm with metformin plus insulin detemir.
Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin levels of metformin plus NPH insulin.
- Being tested
- Insulin Glargin, NPH insulin, Insulin detemir, metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlarginDrug
NPH insulinDrug
Insulin detemirDrug
metforminDrug
metformin (2000 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine | Active comparator | Insulin glargine, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) Receives: Drug: Insulin Glargin; Drug: metformin |
| NPH Insulin | Active comparator | NPH Insulin, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) Receives: Drug: NPH insulin; Drug: metformin |
| Insulin detemir | Active comparator | Insulin detemir, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) Receives: Drug: Insulin detemir; Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial dynamics of intact proinsulin secretion after standardized test meals (AUC for two hours after dinner)
Measured: 12 +/- 2 weeks
Secondary outcomes (11)
AUC for intact proinsulin levels for two hours after a standardized test meal (breakfast and lunch)
Measured: 12 +/- 2 weeks
increase of intact proinsulin after breakfast (BF), lunch (LU) and dinner (DI)
Measured: 12 +/- 2 weeks
Ratio of exogenous insulin vs. endogenous insulin (measurements of glargine, NPH Insulin, detemir and human insulin levels)
Measured: 12 +/- 2 weeks
Postprandial endothelial function measured as postischaemic response in LDF measurements (after BF, LU, DI)
Measured: 12 +/- 2 weeks
Postprandial change in and AUC for hs CRP (after BF, LU, DI)
Measured: 12 +/- 2 weeks
Postprandial change in and AUC for ADMA (after BF, LU, DI)
Measured: 12 +/- 2 weeks
Postprandial increase in and AUC for glucose levels (after BF, LU, DI)
Measured: 12 +/- 2 weeks
Changes in FBG
Measured: 12 +/- 2 weeks
Changes in 8-point BG profiles
Measured: 12 +/- 2 weeks
Percentage of patients reaching the treatment goal
Measured: 12 +/- 2 weeks
Insulin dosage per kg body weight to reach treatment goal
Measured: 12 +/- 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2009
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 Diabetic PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ikfe-CRO GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IKFE Institute for Clinical Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941148
- Sponsor's protocol ID
- LANT_001
- Other IDs
- EudraCT Number: 2007-006109-26
- Status last verified
- Jul 2009
- First submitted
- 16 Jul 2009
- Last updated
- 17 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Forst T, Larbig M, Hohberg C, Forst S, Diessel S, Borchert M, Roth W, Pfutzner A. Adding insulin glargine vs. NPH insulin to metformin results in a more efficient postprandial beta-cell protection in individuals with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):437-41. doi: 10.1111/j.1463-1326.2010.01209.x.
PubMed 20415692
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Insulin (I.)Glargine Compared to NPH I. and to I. Detemir in Combination With Metformin on Prandial ß-cell Function and Overall Metabolic Control in Type 2 Diabetic Patients With Insufficient Metabolic Control During OAD Treatment
- ClinicalTrials.gov ID
- NCT00941148
- Acronym / sponsor ID
- LANT_001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ikfe-CRO GmbHIndustry (pharma, biotech, devices)
- Collaborators
- IKFE Institute for Clinical Research and Development
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Jul 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.
The aim of the study is to show that treatment with Glargine will lead to an improvement in beta cell function especially within times of maximal beta cell stress occurring after a meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will be performed and the postprandial secretion of intact proinsulin levels will be measured. These measurements will be performed with patients treated in combination with metformin and insulin glargine versus metformin plus NPH insulin (within the core study) and if significant difference is observed, with a third treatment arm with metformin plus insulin detemir.
Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin levels of metformin plus NPH insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine | Active comparator | Drug: Insulin Glargin, Drug: metforminInsulin glargine, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) |
| NPH Insulin | Active comparator | Drug: NPH insulin, Drug: metforminNPH Insulin, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) |
| Insulin detemir | Active comparator | Drug: Insulin detemir, Drug: metforminInsulin detemir, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 Diabetes mellitus according to the ADA criteria
- HbA1c between 6.5% and 8.5%
- Individually optimized combination therapy with metformin in combination with sulfonylurea in a stable dosage within the last 3 months
- Age between 40 and 75 years
- Fasting intact proinsulin level > 7 pmol/Land < 20 pmol/Lat screening
Key exclusion criteria (14 listed)
- Type 1 Diabetes mellitus
- Pre-Treatment with insulin within the last 3 months prior to screening
- Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening
- Major micro- or macrovascular complications as judged by the investigator
- BMI > 40 kg/m²
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 Glargin | Drug | Insulin glargine |
| NPH insulin | Drug | NPH Insulin |
| Insulin detemir | Drug | Insulin detemir |
| metforminmetformin (2000 mg/day) | Drug | Insulin detemir, Insulin glargine, NPH Insulin |
Primary outcome
postprandial dynamics of intact proinsulin secretion after standardized test meals (AUC for two hours after dinner)
Time frame: 12 +/- 2 weeks
11 secondary outcomes
AUC for intact proinsulin levels for two hours after a standardized test meal (breakfast and lunch)
Time frame: 12 +/- 2 weeks
increase of intact proinsulin after breakfast (BF), lunch (LU) and dinner (DI)
Time frame: 12 +/- 2 weeks
Ratio of exogenous insulin vs. endogenous insulin (measurements of glargine, NPH Insulin, detemir and human insulin levels)
Time frame: 12 +/- 2 weeks
Postprandial endothelial function measured as postischaemic response in LDF measurements (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Postprandial change in and AUC for hs CRP (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Postprandial change in and AUC for ADMA (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Postprandial increase in and AUC for glucose levels (after BF, LU, DI)
Time frame: 12 +/- 2 weeks
Changes in FBG
Time frame: 12 +/- 2 weeks
Changes in 8-point BG profiles
Time frame: 12 +/- 2 weeks
Percentage of patients reaching the treatment goal
Time frame: 12 +/- 2 weeks
Insulin dosage per kg body weight to reach treatment goal
Time frame: 12 +/- 2 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 17 Jul 2009.
- Derived from this study: PubMed 20415692Forst T, Larbig M, Hohberg C, Forst S, Diessel S, Borchert M, Roth W, Pfutzner A. Adding insulin glargine vs. NPH insulin to metformin results in a more efficient postprandial beta-cell protection in individuals with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):437-41. doi: 10.1111/j.1463-1326.2010.01209.x.
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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.
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 Insulin Glargin, NPH insulin and Insulin detemir in people with Type 2 Diabetic Patients and Insufficient Metabolic Control, run by ikfe-CRO 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 5 inclusion and 14 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 17 Jul 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 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?
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?
postprandial dynamics of intact proinsulin secretion after standardized test meals (AUC for two hours after dinner) (time frame: 12 +/- 2 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 NCT00941148, 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 17 Jul 2009.