Insulin-requiring Type 2 Diabetes MellitusPhase 4NCT01500850
Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
A Phase 4 study testing nph insulin, human insulin and Insulin Glargine in people with Insulin-requiring Type 2 Diabetes Mellitus, run by ikfe-CRO GmbH at 1 site in Germany.
Trial summary
The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin-requiring Type 2 Diabetes Mellitus
- What is being tested?
- nph insulin, human insulin and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give written informed consent.
- Patient consents that his/her family physician/diabetologist will be informed of trial participation
- Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)
- Experienced in self blood glucose measurement for ≥ 3 months.
- HbA1c ≤ 9% and >6,5%
- BMI > 30 kg/m²
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- Age ≥ 18 years
- Waist circumference > 88 cm (female) and > 102 cm (male)
- NPH insulin treatment plus 1 or 2 OAD (except TZD)
Who cannot join
- History of drug or alcohol abuse within the last five years prior to screening
- Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) 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 >1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
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- Pregnant or lactating women
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
- Treatment with GLP1-analog or Thiazolidinediones (TZD)
- hsCRP > 10 mg/l (by rapid test at screening visit).
- Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
- Type 1 Diabetes mellitus
- Patients already treated with intensified conventional insulin therapy.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
ikfe GmbH
Mainz, Rhineland-Palatinate, 55116
Thomas Forst, MD, +49(0) 6131-576 36 -40 ext. 16, thomasf@ikfe.de
Daniela Sachsenheimer, MD, +49(0) 6131-576 36 40 ext. 46, danielas@ikfe.de
About this study
Official title: Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.
The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.
Read the detailed description
- Phase IV
- Indication: Diabetes mellitus Type 2
- Primary objective:
To compare fasting intact proinsulin secretion at the beginning and after a 24 week treatment period.
- Secondary objectives: To evaluate changes in the parameters
- insulin,
- glucose,
- intact proinsulin (after a glucose challenge),
- hsCRP,
- adiponectin,
- MMP-9,
- HbA1c,
- weight after 24 weeks of treatment.
To investigate the changes of
- glucose,
- intact proinsulin,
- hsCRP,
- adiponectin,
- HbA1c
- weight between visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks).
To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).
-Primary efficacy variable: Fasting intact proinsulin concentration at timepoint Visit 2 (Baseline) and Visit 8 (after 24 week treatment)
-Secondary efficacy variables: All secondary parameters will be assessed after 24 weeks of treatment and compared versus baseline assessment.
- Weight
- hsCRP
- Adiponectin
- MMP-9
- OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks
- HOMA-IR score
- HbA1c
Additionally the following parameters will be assessed at visit 6 and will be compared with visit 2 and visit 8:
- Weight
- hsCRP
- Adiponectin
- Fasting intact Proinsulin
- Glucose
- HbA1c
- Safety Variables:
- Adverse Events
- Hypoglycaemic events
Medication/Dosage:
Insulin glargine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)NPH Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Insulin glulisine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Human Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)
-Study Duration: Duration of study participation for one patient is approximately 26 weeks. Overall total duration of the study is approximately 10 months.
Design:
This is a randomized in four arms, open-label, multi-center study. Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm)
- Being tested
- nph insulin, human insulin, Insulin Glargine, Insulin glulisine
- Keywords
- Type 2 Diabetes mellitus, NPH insulin, Insulin Glargine, cardiovascular biomarkers, hsCRP, adiponectin, intact proinsulin, cardiovascular risk
- 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.
nph insulinDrug
Also called Insuman Basal
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
human insulinDrug
Also called Insuman Rapid
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
human insulin: bolus injections before each main meal
Insulin GlargineDrug
Also called Lantus
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
Insulin glulisineDrug
Also called Apidra
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
Insulin glulisine: bolus injections before each main meal
| Study group | Role | What they receive |
|---|---|---|
| NPH insulin + insulin glulisine | Active comparator | Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks. Receives: Drug: nph insulin; Drug: Insulin glulisine |
| NPH insulin + human insulin | Active comparator | Patients will be randomized to be treated with NPH insulin + human insulin for 24 weeks. Receives: Drug: human insulin |
| Insulin glargine + insulin glulisine | Experimental | Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks. Receives: Drug: Insulin Glargine; Drug: Insulin glulisine |
| Insulin Glargine + Human insulin | Experimental | Patients will be randomized to be treated with insulin glargine + human insulin for 24 weeks. Receives: Drug: human insulin; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Intact Proinsulin
The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline.
Measured: Change from baseline at 24 weeks
Secondary outcomes (15)
Weight
To evaluate the changes of weight after 24 weeks of treatment compared to baseline.
Measured: Baseline and after 24 weeks of treatment.
hsCRP
To evaluate changes of hsCRP after 24 weeks of treatment compared to baseline.
Measured: Baseline and after 24 weeks of treatment.
Adiponectin
To evaluate changes of adiponectin after 24 weeks of treatment compared to baseline.
Measured: Baseline and after 24 weeks of treatment.
MMP-9
To evaluate changes of MMP-9 after 24 weeks of treatment compared to baseline.
Measured: Baseline and after 24 weeks of treatment.
OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks
To evaluate changes of OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes) after 24 weeks of treatment compared to baseline.
Measured: Baseline and after 24 weeks of treatment.
HOMA-IR score
To evaluate changes of HOMA-IR score after 24 weeks of treatment compared to baseline.
Measured: Baseline and after 24 weeks of treatment.
HbA1c
To evaluate changes of HbA1C after 24 weeks of treatment compared to baseline.
Measured: Baseline and after 24 weeks of treatment.
Weight
To evaluate changes of weight after 12 weeks of treatment compared to baseline and compared to 24 weeks.
Measured: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
hsCRP
To evaluate changes of hsCRP after 12 weeks of treatment compared to baseline and compared to 24 weeks.
Measured: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Adiponectin
To evaluate changes of adiponectin after 12 weeks of treatment compared to baseline and compared to 24 weeks.
Measured: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Fasting intact Proinsulin
To evaluate changes of fasting intact proinsulin after 12 weeks of treatment compared to baseline and compared to 24 weeks.
Measured: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Glucose
To evaluate changes of Glucose after 12 weeks of treatment compared to baseline and compared to 24 weeks.
Measured: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
HbA1c
To evaluate changes of HbA1c after 12 weeks of treatment compared to baseline and compared to 24 weeks.
Measured: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Responder rate
To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).
Measured: After 24 weeks of treatment compared to baseline.
Hypoglycemic events.
Hypoglycemic events defined as blood glucose below 63 mg/dl.
Measured: Baseline up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startOct 2011
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin-requiring Type 2 Diabetes MellitusStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ikfe-CRO GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IKFE Institute for Clinical Research and Development
- Responsible party
- Sponsor
- Investigators
- Andreas Pfützner, Professor, Principal investigator, Ikfe GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500850
- Sponsor's protocol ID
- Lantu_L_05720
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PubMed 33166419
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.
- ClinicalTrials.gov ID
- NCT01500850
- Acronym / sponsor ID
- Lantu_L_05720
- Keywords
- Type 2 Diabetes mellitus, NPH insulin, Insulin Glargine, cardiovascular biomarkers, hsCRP, adiponectin, intact proinsulin, cardiovascular risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ikfe-CRO GmbHIndustry (pharma, biotech, devices)
- Collaborators
- IKFE Institute for Clinical Research and Development
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 29 Dec 2011 (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 this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.
Detailed description
- Phase IV
- Indication: Diabetes mellitus Type 2
- Primary objective:
To compare fasting intact proinsulin secretion at the beginning and after a 24 week treatment period.
- Secondary objectives: To evaluate changes in the parameters
- insulin,
- glucose,
- intact proinsulin (after a glucose challenge),
- hsCRP,
- adiponectin,
- MMP-9,
- HbA1c,
- weight after 24 weeks of treatment.
To investigate the changes of
- glucose,
- intact proinsulin,
- hsCRP,
- adiponectin,
- HbA1c
- weight between visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks).
To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).
-Primary efficacy variable: Fasting intact proinsulin concentration at timepoint Visit 2 (Baseline) and Visit 8 (after 24 week treatment)
-Secondary efficacy variables: All secondary parameters will be assessed after 24 weeks of treatment and compared versus baseline assessment.
- Weight
- hsCRP
- Adiponectin
- MMP-9
- OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks
- HOMA-IR score
- HbA1c
Additionally the following parameters will be assessed at visit 6 and will be compared with visit 2 and visit 8:
- Weight
- hsCRP
- Adiponectin
- Fasting intact Proinsulin
- Glucose
- HbA1c
- Safety Variables:
- Adverse Events
- Hypoglycaemic events
Medication/Dosage:
Insulin glargine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)NPH Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Insulin glulisine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Human Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)
-Study Duration: Duration of study participation for one patient is approximately 26 weeks. Overall total duration of the study is approximately 10 months.
Design:
This is a randomized in four arms, open-label, multi-center study. Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NPH insulin + insulin glulisine | Active comparator | Drug: nph insulin, Drug: Insulin glulisinePatients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks. |
| NPH insulin + human insulin | Active comparator | Drug: human insulinPatients will be randomized to be treated with NPH insulin + human insulin for 24 weeks. |
| Insulin glargine + insulin glulisine | Experimental | Drug: Insulin Glargine, Drug: Insulin glulisinePatients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks. |
| Insulin Glargine + Human insulin | Experimental | Drug: human insulin, Drug: Insulin GlarginePatients will be randomized to be treated with insulin glargine + human insulin for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Give written informed consent.
- Patient consents that his/her family physician/diabetologist will be informed of trial participation
- Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)
- Experienced in self blood glucose measurement for ≥ 3 months.
- HbA1c ≤ 9% and >6,5%
Key exclusion criteria (13 listed)
- History of drug or alcohol abuse within the last five years prior to screening
- Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) 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
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 |
|---|---|---|
| nph insulinAlso: Insuman BasalDosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL. | Drug | NPH insulin + insulin glulisine |
| human insulinAlso: Insuman RapidDosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL. human insulin: bolus injections before each main meal | Drug | Insulin Glargine + Human insulin, NPH insulin + human insulin |
| Insulin GlargineAlso: LantusDosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL. | Drug | Insulin Glargine + Human insulin, Insulin glargine + insulin glulisine |
| Insulin glulisineAlso: ApidraDosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL. Insulin glulisine: bolus injections before each main meal | Drug | Insulin glargine + insulin glulisine, NPH insulin + insulin glulisine |
Primary outcome
Fasting Intact Proinsulin
Time frame: Change from baseline at 24 weeks
The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline.
15 secondary outcomes
Weight
Time frame: Baseline and after 24 weeks of treatment.
hsCRP
Time frame: Baseline and after 24 weeks of treatment.
Adiponectin
Time frame: Baseline and after 24 weeks of treatment.
MMP-9
Time frame: Baseline and after 24 weeks of treatment.
OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks
Time frame: Baseline and after 24 weeks of treatment.
HOMA-IR score
Time frame: Baseline and after 24 weeks of treatment.
HbA1c
Time frame: Baseline and after 24 weeks of treatment.
Weight
Time frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
hsCRP
Time frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Adiponectin
Time frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Fasting intact Proinsulin
Time frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Glucose
Time frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
HbA1c
Time frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.
Responder rate
Time frame: After 24 weeks of treatment compared to baseline.
Hypoglycemic events.
Time frame: Baseline up to 24 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
- Derived from this study: PubMed 33166419Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
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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.
Andreas Pfützner, Professor 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 nph insulin, human insulin and Insulin Glargine in people with Insulin-requiring Type 2 Diabetes Mellitus, 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 9 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: status not confirmed, as of the sponsor's last update on 29 Dec 2011. 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 Andreas Pfützner, Professor (00496131-57636-0 ext. 20, andreasp@ikfe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Intact Proinsulin (time frame: Change from baseline at 24 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 NCT01500850, 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 29 Dec 2011.