Diabetes Mellitus, Type 2Phase 4NCT00941369
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
A Phase 4 study testing Insulin Glargine (HOE901)/NPH Insulin in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL). Secondary Objective: A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine (HOE901)/NPH Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.
- Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.
- No pre-treatment with any insulin in the last 3 months before the study.
- Glycated Haemoglobin A1c (HbA1c) value between > or = 7.0 and > or = 9.5%
- Fasting Blood Glucose (FBG) > or = 120 mg/dl (6.7 mmol/l).
- Body mass index < 40 kg/m.
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- Ability to read and understand German language.
- Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.
- Women of childbearing potential who will take adequate contraceptive protection.
Who cannot join
- Patients with type 1 diabetes mellitus.
- Any history of ketoacidosis.
- Pregnancy.
- Prior treatment with insulin.
- Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.
- History of drug or alcohol abuse.
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- Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
- Following pancreatectomy.
- Impaired hepatic function.
- Impaired renal function.
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
- Inability to attend follow-up visits.
- Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).
- Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
- Systemic corticoids > 7,5 mg prednisolon equivalent or <or=7,5 mg prednisolon equivalent for less than 2 months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin
Primary Objective:
To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).
Secondary Objective:
A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:
- Glycaemic parameters: 7 blood glucose profiles
- Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
- Change in lipid status
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine (HOE901)/NPH 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 Glargine (HOE901)/NPH InsulinDrug
Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time
Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician
The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day.
The dose adjustments will be based on the results of self-monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen Receives: Drug: Insulin Glargine (HOE901)/NPH Insulin |
| 2 | Active comparator | Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen Receives: Drug: Insulin Glargine (HOE901)/NPH Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Assessment, Patient treatment satisfaction and Quality-of-Life
Measured: At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)
Secondary outcomes (4)
Glycaemic parameters assessment
Measured: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Anteropometric data (Weight, waist circumference) assessment
Measured: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Lipid assessment
Measured: At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Hypoglycemia assessment
Measured: Throughout the study from starting until the week 48
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 startJun 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heinz Riederer, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941369
- Sponsor's protocol ID
- LANTU_L_04079
- Other IDs
- 2009-019013-59(EudraCT), 2009
- Status last verified
- Nov 2012
- First submitted
- 16 Jul 2009
- Last updated
- 22 Nov 2012
- Results posted
- 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 33166419Hermanns N, Kulzer B, Kohlmann T, Jacob S, Landgraf W, Theobald K, Haak T. Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial. Health Qual Life Outcomes. 2015 Jun 9;13:77. doi: 10.1186/s12955-015-0279-4.
PubMed 26055391
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin
- ClinicalTrials.gov ID
- NCT00941369
- Acronym / sponsor ID
- LANTU_L_04079
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (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.
Primary Objective:
To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).
Secondary Objective:
A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:
- Glycaemic parameters: 7 blood glucose profiles
- Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
- Change in lipid status
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin Glargine (HOE901)/NPH InsulinInsulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen |
| 2 | Active comparator | Drug: Insulin Glargine (HOE901)/NPH InsulinNeutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.
- Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.
- No pre-treatment with any insulin in the last 3 months before the study.
- Glycated Haemoglobin A1c (HbA1c) value between > or = 7.0 and > or = 9.5%
- Fasting Blood Glucose (FBG) > or = 120 mg/dl (6.7 mmol/l).
Key exclusion criteria (17 listed)
- Patients with type 1 diabetes mellitus.
- Any history of ketoacidosis.
- Pregnancy.
- Prior treatment with insulin.
- Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.
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 Glargine (HOE901)/NPH InsulinArm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day. The dose adjustments will be based on the results of self-monitoring. | Drug | 1, 2 |
Primary outcome
Health Assessment, Patient treatment satisfaction and Quality-of-Life
Time frame: At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)
4 secondary outcomes
Glycaemic parameters assessment
Time frame: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Anteropometric data (Weight, waist circumference) assessment
Time frame: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Lipid assessment
Time frame: At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Hypoglycemia assessment
Time frame: Throughout the study from starting until the week 48
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 22 Nov 2012.
- 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.
- Derived from this study: PubMed 26055391Hermanns N, Kulzer B, Kohlmann T, Jacob S, Landgraf W, Theobald K, Haak T. Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial. Health Qual Life Outcomes. 2015 Jun 9;13:77. doi: 10.1186/s12955-015-0279-4.
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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.
Heinz Riederer study director
Sanofi
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 (HOE901)/NPH Insulin in people with Diabetes Mellitus, Type 2, run by Sanofi 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 17 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 22 Nov 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?
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?
Health Assessment, Patient treatment satisfaction and Quality-of-Life (time frame: At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)). 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 NCT00941369, which also lists 2 linked publications.
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 22 Nov 2012.