Diabetes Mellitus Type 2Phase 2NCT01729403
A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin
A Phase 2 study testing aleglitazar and metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- aleglitazar and metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Sep 2013
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, 30 to 70 years of age inclusive at screening
- Type 2 diabetes mellitus patients treated with stable metformin therapy for at least 12 weeks prior to screening; metformin dose should not exceed the maximum dose specified in the label
- HbA1c >/= 6.5% and </= 9% at screening and baseline
- Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dl) at screening and baseline
- Body mass index (BMI) >/= 25 at screening; BMI >/= 27 for subjects with HbA1c < 7%
- Stable weight +/- 5% for at least 12 weeks prior to screening
Who cannot join
- Women who are pregnant, intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
- Diagnosis or history of type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
- Any previous treatment with a thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist
- Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>/= 1 month) statin therapy
- History of bariatric surgery or currently undergoing evaluation for bariatric surgery
Show all 19Show fewer
- Prior intolerance to fibrate
- Treatment with any anti-diabetic medication other than metformin in the last 12 weeks prior to screening and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening
- Clinically apparent liver disease
- Positive for hepatitis B, hepatitis C or HIV infection
- Clinical evidence of anemia
- Symptomatic congestive heart failure (New York Heart Association Class II-IV) at screening
- Myocardial infarction, acute coronary syndrome, or transient ischemic attack/stroke within 6 months prior to screening
- Known macular edema at screening or prior to screening visit
- Uncontrolled hypertension despite stable (for at least 4 weeks) anti-hypertensive treatment
- Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years
- Chronic oral or parenteral corticosteroid treatment (> 2 weeks) within 3 months prior to screening
- History of active substance abuse (including alcohol) within the past 2 years or positive test result for drugs of abuse or alcohol prior to first dosing
- Presence of any absolute or relative contraindication for the conduct of magnetic resonance imaging (MRI) investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Inadequately Controlled With Metformin Monotherapy
This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- aleglitazar, metformin, placebo
- 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.
aleglitazarDrug
150 mcg orally daily, 16 weeks
metforminDrug
patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)
placeboDrug
orally daily, 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aleglitazar | Experimental | Not described Receives: Drug: aleglitazar; Drug: metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: metformin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate)
Measured: from baseline to Week 16
Secondary outcomes (11)
Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance)
Measured: from baseline to Week 16
Change in parameters of beta cell function (first and second phase insulin secretion)
Measured: from baseline to Week 16
Change in HbA1c
Measured: from baseline to Week 16
Change in lipid profile
Measured: from baseline to Week 16
Change in mean 24h blood pressure
Measured: from baseline to Week 16
Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI)
Measured: from baseline to Week 16
Change in fat content/distribution in the abdominal region measured by MRI
Measured: from baseline to Week 16
Change in total body fat content measured by air displacement phlethysmography
Measured: from baseline to Week 16
Change in homeostatic indexes of insulin sensitivity assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-IS)
Measured: from baseline to Week 16
Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid)
Measured: from baseline to Week 16
Safety: Incidence of adverse events
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729403
- Sponsor's protocol ID
- WC28038
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Inadequately Controlled With Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT01729403
- Acronym / sponsor ID
- WC28038
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Nov 2012 (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.
This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aleglitazar | Experimental | Drug: aleglitazar, Drug: metformin |
| Placebo | Placebo comparator | Drug: metformin, Drug: placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, 30 to 70 years of age inclusive at screening
- Type 2 diabetes mellitus patients treated with stable metformin therapy for at least 12 weeks prior to screening; metformin dose should not exceed the maximum dose specified in the label
- HbA1c >/= 6.5% and </= 9% at screening and baseline
- Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dl) at screening and baseline
- Body mass index (BMI) >/= 25 at screening; BMI >/= 27 for subjects with HbA1c < 7%
Key exclusion criteria (19 listed)
- Women who are pregnant, intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
- Diagnosis or history of type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
- Any previous treatment with a thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist
- Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>/= 1 month) statin therapy
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 |
|---|---|---|
| aleglitazar150 mcg orally daily, 16 weeks | Drug | Aleglitazar |
| metforminpatients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label) | Drug | Aleglitazar, Placebo |
| placeboorally daily, 16 weeks | Drug | Placebo |
Primary outcome
Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate)
Time frame: from baseline to Week 16
11 secondary outcomes
Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance)
Time frame: from baseline to Week 16
Change in parameters of beta cell function (first and second phase insulin secretion)
Time frame: from baseline to Week 16
Change in HbA1c
Time frame: from baseline to Week 16
Change in lipid profile
Time frame: from baseline to Week 16
Change in mean 24h blood pressure
Time frame: from baseline to Week 16
Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI)
Time frame: from baseline to Week 16
Change in fat content/distribution in the abdominal region measured by MRI
Time frame: from baseline to Week 16
Change in total body fat content measured by air displacement phlethysmography
Time frame: from baseline to Week 16
Change in homeostatic indexes of insulin sensitivity assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-IS)
Time frame: from baseline to Week 16
Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid)
Time frame: from baseline to Week 16
Safety: Incidence of adverse events
Time frame: 22 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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aleglitazar and metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche 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 19 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 2 Nov 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate) (time frame: from baseline to Week 16). 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 2 Nov 2016.