Diabetes Mellitus, Type 2Phase 4NCT01206647
Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Metformin and Saxagliptin in people with Diabetes Mellitus, Type 2, run by ikfe-CRO GmbH at 7 sites in Germany.
Trial summary
The purpose of this study is to investigate the success rate of a switch from insulin therapy to a metformin \& saxagliptin combination in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin and Saxagliptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesGermany
- Study dates
- Feb 2010to Feb 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT; > 2 injections of basal and prandial) or conventional insulin therapy (CIT; 1 or 2 injections of basal or biphasic)
- HbA1c < 7.5 %
- Age: 18-80 years inclusively
- Duration of insulin therapy > 1 year
- Insulin dose < 120 IU/day
- Fasting C-peptide > 0.6 ng/l
Show all 10Show fewer
- Fasting glucose ≤ 210 mg/dl
- Full legal, mental and physical ability to give informed consent
- Patient consent that the general physician will be informed of trail participation
- Experience in self measurement of blood glucose > 1 year
Who cannot join
- Type 1 Diabetes mellitus
- History of drug or alcohol abuse within the last five years prior to screening
- History of severe or multiple allergies
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
- Renal insufficiency or history of significant renal diseases (creatinine clearance lower than 60 ml/min determined using the Cockroft-Goult equation).
Show all 12Show fewer
- Contra-indications for study drugs including contraindications for the rescue drugs
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- Pregnancy or breast feeding
- 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 vasectomised partner
- Treatment with any other investigational drug within 3 months prior to screening
- Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Diabetologische Schwerpunktpraxis Dr. Lorra / Dr. Bonnermann
Bochum, 44869
Zentrum für klinische Studien Dresden, GWT-TUD GmbH
Dresden, 01307
Gemeinschaftspraxis Partner der Gesundheit
Essen, 45355
IKFE Institute for Clinical Research and Development
Mainz, 55116
Zentrum für Diabetes und Gefäßerkrankungen
Münster, 48145
Diabetes Zentrum Neuwied
Neuwied, 56564
ikfe Studiencenter Potsdam GmbH
Potsdam, 14469
About this study
The purpose of this study is to investigate the success rate of a switch from insulin therapy to a metformin \& saxagliptin combination in patients with type 2 diabetes mellitus.
Read the detailed description
The following study is based on a previous clinical trial performed at ikfe GmbH in Mainz in 2006 and 2007 (PIOswitch). [2] The purpose of this trial was to demonstrate that type 2 diabetes patients treated with insulin can be effectively switched to a pioglitazone/glimepiride combination without loss of glycemic control. The study was performed with 100 patients, out of whom 76 were finally successfully switched, resulting in a cheaper and more convenient therapy with indications of an improved laboratory cardiovascular risk biomarker profile (Hohberg et al., Diabetes Obes. Metab. 11:464-471, 2009). [2] Glimeperide is an agent with unspecific stimulating effect on the ß-cell and is considered to accelerate the progression of the disease while still controlling blood glucose. In addition, it may cause hypoglycemia. The combination of pioglitazone with glimepiride was selected, because pioglitazone requires approx. 5-6 weeks for developing its full anti-diabetic efficacy and an immediate effect on glucose was required to avoid glycemic deterioration.
It is tempting to speculate that the combination of a drug providing ß-cell protection (like saxagliptin) with a drug effectively and rapidly lowering blood glucose through a different mechanism of action (metformin) instead of unspecific ß-cell stimulation would result in an even improved outcome without risk of hypoglycemia. The purpose of this study is to investigate the success rate of a switch from insulin therapy to a metformin \& saxagliptin combination in patients with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin and Saxagliptin
- 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.
Metformin and SaxagliptinDrug
Metformin 500mg/daily titrated to 2000mg/d in 4 Weeks (continued for 20 weeks) Saxagliptin 5 mg daily over complete trial
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | The patients randomized to the control arm will continue their current therapy, as individually prescribed. Insulin will be administered via subcutaneous injection and OADs (if applicable) will be administered orally, as individually prescribed. |
| Saxagliptin & metformin | Experimental | Saxagliptin and metformin tablets will be administered orally. Pioglitazione (Rescue medication) tablets will be administered orally. Insulin glargine (Rescue medication) will be administered via subcutaneous injection as individually prescribed. Receives: Drug: Metformin and Saxagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with stable HbA1c
Measured: 26 ± 2 weeks (baseline to postbaseline values) at 4 week intervals
Secondary outcomes (7)
impact of the switch on:
- Biomarkers of insulin resistance and ß-cell function
Measured: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
- Biomarkers of cardiovaskular risk
Measured: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
- Patient treatment satifaction
Measured: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
- Treatment costs
Measured: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
- Requirement of 3rd line OAD pioglitazone as rescue drug
Measured: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
- oral Glucose Tolerance Test (oGTT)
Measured: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
- Macrophagen activation (in a subpopulation at site 01 ikfe GmbH)
Measured: 26 ± 2 weeks (baseline to postbaseline values)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ikfe-CRO GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, IKFE Institute for Clinical Research and Development
- Investigators
- Andreas Pfützner, Prof.Dr.Dr., Principal investigator, IKFE Institute for Clinical Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206647
- Sponsor's protocol ID
- AZ-SAX-001
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 22 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01206647
- Acronym / sponsor ID
- AZ-SAX-001
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ikfe-CRO GmbHIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, IKFE Institute for Clinical Research and Development
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 22 Sep 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.
The purpose of this study is to investigate the success rate of a switch from insulin therapy to a metformin \& saxagliptin combination in patients with type 2 diabetes mellitus.
Detailed description
The following study is based on a previous clinical trial performed at ikfe GmbH in Mainz in 2006 and 2007 (PIOswitch). [2] The purpose of this trial was to demonstrate that type 2 diabetes patients treated with insulin can be effectively switched to a pioglitazone/glimepiride combination without loss of glycemic control. The study was performed with 100 patients, out of whom 76 were finally successfully switched, resulting in a cheaper and more convenient therapy with indications of an improved laboratory cardiovascular risk biomarker profile (Hohberg et al., Diabetes Obes. Metab. 11:464-471, 2009). [2] Glimeperide is an agent with unspecific stimulating effect on the ß-cell and is considered to accelerate the progression of the disease while still controlling blood glucose. In addition, it may cause hypoglycemia. The combination of pioglitazone with glimepiride was selected, because pioglitazone requires approx. 5-6 weeks for developing its full anti-diabetic efficacy and an immediate effect on glucose was required to avoid glycemic deterioration.
It is tempting to speculate that the combination of a drug providing ß-cell protection (like saxagliptin) with a drug effectively and rapidly lowering blood glucose through a different mechanism of action (metformin) instead of unspecific ß-cell stimulation would result in an even improved outcome without risk of hypoglycemia. The purpose of this study is to investigate the success rate of a switch from insulin therapy to a metformin \& saxagliptin combination in patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –The patients randomized to the control arm will continue their current therapy, as individually prescribed. Insulin will be administered via subcutaneous injection and OADs (if applicable) will be administered orally, as individually prescribed. |
| Saxagliptin & metformin | Experimental | Drug: Metformin and SaxagliptinSaxagliptin and metformin tablets will be administered orally. Pioglitazione (Rescue medication) tablets will be administered orally. Insulin glargine (Rescue medication) will be administered via subcutaneous injection as individually prescribed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT; > 2 injections of basal and prandial) or conventional insulin therapy (CIT; 1 or 2 injections of basal or biphasic)
- HbA1c < 7.5 %
- Age: 18-80 years inclusively
- Duration of insulin therapy > 1 year
- Insulin dose < 120 IU/day
Key exclusion criteria (12 listed)
- Type 1 Diabetes mellitus
- History of drug or alcohol abuse within the last five years prior to screening
- History of severe or multiple allergies
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
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 |
|---|---|---|
| Metformin and SaxagliptinMetformin 500mg/daily titrated to 2000mg/d in 4 Weeks (continued for 20 weeks) Saxagliptin 5 mg daily over complete trial | Drug | Saxagliptin & metformin |
Primary outcome
percentage of patients with stable HbA1c
Time frame: 26 ± 2 weeks (baseline to postbaseline values) at 4 week intervals
7 secondary outcomes
impact of the switch on:
Time frame: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
Time frame: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
Time frame: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
Time frame: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
Time frame: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
Time frame: 26 ± 2 weeks (baseline to postbaseline values)
impact of the switch on:
Time frame: 26 ± 2 weeks (baseline to postbaseline values)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2010.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Andreas Pfützner, Prof.Dr.Dr. principal investigator
IKFE Institute for Clinical Research and Development
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Saxagliptin in people with Diabetes Mellitus, Type 2, run by ikfe-CRO GmbH at 7 sites 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 10 inclusion and 12 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 22 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
percentage of patients with stable HbA1c (time frame: 26 ± 2 weeks (baseline to postbaseline values) at 4 week intervals). 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 22 Sep 2010.