Type 2 DiabetesPhase 4NCT01249677
Chronic Reduction of Fasting Glycaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes
A Phase 4 study testing insulin glargine in people with Type 2 Diabetes, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2 diabetes. The investigators examined, whether chronic basal insulin treatment with insulin glargine lead to improvements in glucose-induced insulin secretion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- insulin glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to May 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years, inclusive
- BMI-range 27-50 kg/m²
- patients with type 2 diabetes presenting with fasting hyperglycaemia (>126mg/dl) on metformin treatment
Who cannot join
- 1.Pre-existing insulin therapy, treatment with sulphonylureas, glitazones, 2.glinides, DPP-4-inhibitors or exenatide 3.patients with type 1 diabetes 4.Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- 5. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner). A male subject who is sexually active and has not been surgically sterilised must be informed that he must either use a condom during intercourse, ensure that his partner practices contraception, or he must refrain from sexual intercourse during the trial and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication. It is strongly recommended that the female partners use a highly effective contraception (Pearl Index < 1%).
- 6. Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
- 7. Patients have alcohol consumption (>20 g daily for males and >10 g daily for females) 8. Patients have alanine aminotransaminase (ALT) greater than ten times the upper limit of the reference range.
- 9.Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.
- 10. Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria.
Show all 9Show fewer
- 11. Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >1.8 mg/dL for males and greater than or equal to >1.5 mg/dL for females. 12.Patients have known hemoglobinopathy or chronic anemia 13.Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
- 14. Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator.
- 15. Patients fail to satisfy the investigator of suitability to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine I; University Hospital St. Josef Hospital
Bochum
About this study
Official title: Chronic Reduction of Fasting Gylcaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes
Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2 diabetes. The investigators examined, whether chronic basal insulin treatment with insulin glargine lead to improvements in glucose-induced insulin secretion.
Read the detailed description
14 patients with type 2 diabetes on previous metformin therapy were examined before and after eight weeks of treatment with insulin glargine, aimed to normalize fasting glycaemia. Intravenous glucose tolerance tests were performed with and without previous adjustment of fasting glucose levels by means of a 3-hour intravenous insulin infusion.
- Conditions
- Type 2 Diabetes
- Being tested
- insulin glargine
- Keywords
- type 2 diabetes, first phase insulin secretion, beta-cell rest, basal 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 glargineDrug
Also called Lantus
14 patients with type 2 diabetes on previous metformin therapy were treated with insulin glargine, aimed to normalize fasting glycaemia.
| Study group | Role | What they receive |
|---|---|---|
| insulin glargine | Experimental | patients with type 2 diabetes on previous therapy with metformin were examined before and after eight weeks of treatment with insulin glargin, aimed to normalize fasting plasma glycaemia Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in first and second phase insulin secretion
Improvements in first and second phase insulin secretion after bedtime administration of insulin glargin, titrated to reach normal (90-100 mg/dl) fasting glucose levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJan 2009
- Primary completionMay 2010
- Study completionMay 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249677
- Sponsor's protocol ID
- 08- BO-LSBE
- Status last verified
- Oct 2008
- First submitted
- 29 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pennartz C, Schenker N, Menge BA, Schmidt WE, Nauck MA, Meier JJ. Chronic reduction of fasting glycemia with insulin glargine improves first- and second-phase insulin secretion in patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2048-53. doi: 10.2337/dc11-0471. Epub 2011 Jul 20.
PubMed 21775756
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Reduction of Fasting Gylcaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01249677
- Acronym / sponsor ID
- 08- BO-LSBE
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, first phase insulin secretion, beta-cell rest, basal insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Nov 2010 (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.
Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2 diabetes. The investigators examined, whether chronic basal insulin treatment with insulin glargine lead to improvements in glucose-induced insulin secretion.
Detailed description
14 patients with type 2 diabetes on previous metformin therapy were examined before and after eight weeks of treatment with insulin glargine, aimed to normalize fasting glycaemia. Intravenous glucose tolerance tests were performed with and without previous adjustment of fasting glucose levels by means of a 3-hour intravenous insulin infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin glargine | Experimental | Drug: insulin glarginepatients with type 2 diabetes on previous therapy with metformin were examined before and after eight weeks of treatment with insulin glargin, aimed to normalize fasting plasma glycaemia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years, inclusive
- BMI-range 27-50 kg/m²
- patients with type 2 diabetes presenting with fasting hyperglycaemia (>126mg/dl) on metformin treatment
Key exclusion criteria (9 listed)
- 1.Pre-existing insulin therapy, treatment with sulphonylureas, glitazones, 2.glinides, DPP-4-inhibitors or exenatide 3.patients with type 1 diabetes 4.Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- 5. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner). A male subject who is sexually active and has not been surgically sterilised must be informed that he must either use a condom during intercourse, ensure that his partner practices contraception, or he must refrain from sexual intercourse during the trial and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication. It is strongly recommended that the female partners use a highly effective contraception (Pearl Index < 1%).
- 6. Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
- 7. Patients have alcohol consumption (>20 g daily for males and >10 g daily for females) 8. Patients have alanine aminotransaminase (ALT) greater than ten times the upper limit of the reference range.
- 9.Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.
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 glargineAlso: Lantus14 patients with type 2 diabetes on previous metformin therapy were treated with insulin glargine, aimed to normalize fasting glycaemia. | Drug | insulin glargine |
Primary outcome
Improvements in first and second phase insulin secretion
Time frame: 8 weeks
Improvements in first and second phase insulin secretion after bedtime administration of insulin glargin, titrated to reach normal (90-100 mg/dl) fasting glucose levels
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 30 Nov 2010.
- Derived from this study: PubMed 21775756Pennartz C, Schenker N, Menge BA, Schmidt WE, Nauck MA, Meier JJ. Chronic reduction of fasting glycemia with insulin glargine improves first- and second-phase insulin secretion in patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2048-53. doi: 10.2337/dc11-0471. Epub 2011 Jul 20.
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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 glargine in people with Type 2 Diabetes, run by Ruhr University of Bochum 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 3 inclusion and 9 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 30 Nov 2010. 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?
Improvements in first and second phase insulin secretion (time frame: 8 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 NCT01249677, 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 30 Nov 2010.