Type 2 DiabetesPhase 4NCT00609856
Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
A Phase 4 study testing pioglitazone and insulin glargine in people with Type 2 Diabetes and Secondary Drug Failure, run by Skane University Hospital at 1 site in Sweden.
Trial summary
Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Secondary Drug Failure
- What is being tested?
- pioglitazone and insulin glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2004to Dec 2006
- 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
- inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin
Who cannot join
- heart failure (NYHA II-IV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.
Read the detailed description
The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:
- Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test
- Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and
- Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.
- Conditions
- Type 2 Diabetes, Secondary Drug Failure
- Being tested
- pioglitazone, insulin glargine
- 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.
pioglitazoneDrug
Also called Actos
tablet, 30 mg, once daily, 26 weeks
insulin glargineDrug
Also called Lantus
subcutaneous injection, start dose 6-10 units, once daily, 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pioglitazone Receives: Drug: pioglitazone |
| 2 | Active comparator | Insulin glargine Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
Measured: 26 weeks
Secondary outcomes (1)
Effect of pioglitazone vs. insulin glargine on BNP
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startApr 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Skane County Council Research & Development Foundation
- Investigators
- Leif Groop, Professor, Study director, Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609856
- Sponsor's protocol ID
- Dnr 111/2004
- Other IDs
- 0
- Status last verified
- Jan 2008
- First submitted
- 24 Jan 2008
- Last updated
- 7 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00609856
- Acronym / sponsor ID
- Dnr 111/2004
- Conditions
- Type 2 Diabetes, Secondary Drug Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Medical Research Council, Skane County Council Research & Development Foundation
- Study start
- Apr 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Feb 2008 (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.
Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.
Detailed description
The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:
- Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test
- Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and
- Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: pioglitazonePioglitazone |
| 2 | Active comparator | Drug: insulin glargineInsulin glargine |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes
- inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin
Key exclusion criteria (1 listed)
- heart failure (NYHA II-IV)
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 |
|---|---|---|
| pioglitazoneAlso: Actostablet, 30 mg, once daily, 26 weeks | Drug | 1 |
| insulin glargineAlso: Lantussubcutaneous injection, start dose 6-10 units, once daily, 26 weeks | Drug | 2 |
Primary outcome
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
Time frame: 26 weeks
1 secondary outcome
Effect of pioglitazone vs. insulin glargine on BNP
Time frame: 26 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 7 Feb 2008.
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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.
Leif Groop, Professor study director
Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden
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 pioglitazone and insulin glargine in people with Type 2 Diabetes and Secondary Drug Failure, run by Skane University Hospital at 1 site in Sweden.
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 2 inclusion and 1 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 7 Feb 2008. 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 Sweden. 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?
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity (time frame: 26 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 7 Feb 2008.