Type 2 Diabetes MellitusPhase 4HERMESNCT01417897
Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
A Phase 4 study testing Insulin glulisine, Insulin aspart and Regular human insulin in people with Type 2 Diabetes Mellitus, run by ikfe-CRO GmbH at 1 site in Germany.
Trial summary
The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin glulisine, Insulin aspart and Regular human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to May 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Stable BOT (basal oral therapy) with Insulin Glargine + ≥ 2 OHA (oral hypoglycemic agents except for TZD) for a minimum of three months before entering the study
- HbA1c ≤ 8.5%
- Age between 30 and 75 years inclusively
- Body mass index ≤ 40 kg/m2
- Patient consents that his/her family physician will be informed of trial participation
Who cannot join
- Type 1 diabetes mellitus
- Unspecific infection or inflammation (hsCRP >10mg/L in POC test)
- Use of thiazolidinediones within the last 3 months prior to study start
- Retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
- History of drug or alcohol abuse within the last five years prior to screening
- History of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
Show all 13Show fewer
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- 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
- 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
- Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin glulisine, Insulin aspart, Regular human insulin
- 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 glulisineDrug
Also called Apidra
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Insulin aspartDrug
Also called NovoRapid
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Regular human insulinDrug
Also called InsumanRapid
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glulisine: bolus injections before each main meal | Experimental | Patients are already on an Insulin Glargine therapy when they start and will them after randomization receive additionally Insulin Glulisine bolus injections before each of the main meals. Receives: Drug: Insulin glulisine |
| Insulin Aspart: bolus injections before each main meal | Active comparator | Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally Insulin Aspart bolus injections before each of the main meals. Receives: Drug: Insulin aspart |
| Regular human insulin:bolus injections before each main meal | Active comparator | Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally regular human insulin bolus injections before each of the main meals. Receives: Drug: Regular human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitrotyrosine
The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal
Measured: Baseline, after 10 weeks, after 24 weeks
Secondary outcomes (7)
Skin blood flow
Change in skin blood flow during stimulation by a standardized meal
Measured: Baseline, after 10 weeks, after 24 weeks
mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)
Biomarkers of sub-clinical inflammation and cardiovascular risk: Change in Macrophage activation, MAPK/eNOS production levels, adiponectin and hsCRP (after test meal) from baseline to endpoint
Measured: Baseline, after 10 weeks, after 24 weeks
Insulin
Change in Insulin and the ratio from baseline to endpoint
Measured: Baseline, after 10 weeks, after 24 weeks
HbA1c
Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint
Measured: Baseline, after 10 weeks, after 24 weeks
Fasting blood glucose
Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint
Measured: Baseline, after 10 weeks, after 24 weeks
Hypoglycemic events
Incidence of hypoglycemia from baseline to endpoint
Measured: Baseline, after 10 weeks, after 24 weeks
intact Proinsulin
Change in intact Proinsulin and the ratio from baseline to endpoint
Measured: Baseline, after 10 weeks, after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 12 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
- Principal investigator, Marcus Borchert, ikfe-CRO GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417897
- Sponsor's protocol ID
- APIDR_L_05719
- Acronym
- HERMES
- Status last verified
- Mar 2012
- First submitted
- 15 Aug 2011
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
- ClinicalTrials.gov ID
- NCT01417897
- Acronym / sponsor ID
- HERMES / APIDR_L_05719
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- ikfe-CRO GmbHIndustry (pharma, biotech, devices)
- Collaborators
- IKFE Institute for Clinical Research and Development
- Study start
- Sep 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 16 Aug 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 planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin Glulisine: bolus injections before each main meal | Experimental | Drug: Insulin glulisinePatients are already on an Insulin Glargine therapy when they start and will them after randomization receive additionally Insulin Glulisine bolus injections before each of the main meals. |
| Insulin Aspart: bolus injections before each main meal | Active comparator | Drug: Insulin aspartPatients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally Insulin Aspart bolus injections before each of the main meals. |
| Regular human insulin:bolus injections before each main meal | Active comparator | Drug: Regular human insulinPatients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally regular human insulin bolus injections before each of the main meals. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus
- Stable BOT (basal oral therapy) with Insulin Glargine + ≥ 2 OHA (oral hypoglycemic agents except for TZD) for a minimum of three months before entering the study
- HbA1c ≤ 8.5%
- Age between 30 and 75 years inclusively
- Body mass index ≤ 40 kg/m2
Key exclusion criteria (13 listed)
- Type 1 diabetes mellitus
- Unspecific infection or inflammation (hsCRP >10mg/L in POC test)
- Use of thiazolidinediones within the last 3 months prior to study start
- Retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
- History of drug or alcohol abuse within the last five years prior to 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 glulisineAlso: ApidraDosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. | Drug | Insulin Glulisine: bolus injections before each main meal |
| Insulin aspartAlso: NovoRapidDosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. | Drug | Insulin Aspart: bolus injections before each main meal |
| Regular human insulinAlso: InsumanRapidDosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. | Drug | Regular human insulin:bolus injections before each main meal |
Primary outcome
Nitrotyrosine
Time frame: Baseline, after 10 weeks, after 24 weeks
The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal
7 secondary outcomes
Skin blood flow
Time frame: Baseline, after 10 weeks, after 24 weeks
mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)
Time frame: Baseline, after 10 weeks, after 24 weeks
Insulin
Time frame: Baseline, after 10 weeks, after 24 weeks
HbA1c
Time frame: Baseline, after 10 weeks, after 24 weeks
Fasting blood glucose
Time frame: Baseline, after 10 weeks, after 24 weeks
Hypoglycemic events
Time frame: Baseline, after 10 weeks, after 24 weeks
intact Proinsulin
Time frame: Baseline, after 10 weeks, after 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
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 glulisine, Insulin aspart and Regular human insulin in people with 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 6 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 5 Mar 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?
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?
Nitrotyrosine (time frame: Baseline, after 10 weeks, after 24 weeks). 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 5 Mar 2012.