Type 2 Diabetes MellitusPhase 2NCT01824264
Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes
A Phase 2 study testing LIK066 and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals.
Trial summary
The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LIK066 and Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of T2DM by standard criteria
- Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
- Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1
- Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI)
- HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients
- HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy
Show all 9Show fewer
- HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients
- Age: ≥18 and ≤ 75 years old at Visit 1
- BMI ≥22 to ≤45 kg/m2 at Visit 1
Who cannot join
- FPG ≥270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1
- Insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
- History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
- Significant lab abnormalities such as TSH outside of normal range, UACR>300 mg/g creatinine, eGFR <60 ml/min/1.73m2, hemoglobin <12 g/L in men and <11 g/L in women, hematuria
- ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >470 msec for women
- History of malignancy
- Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Evaluate Change in HbA1c After 12 Weeks Monotherapy With 7 Doses of LIK066 Compared With Placebo or Sitagliptin in Patients With Type 2 Diabetes
The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LIK066, Sitagliptin, Placebo
- Keywords
- Type 2 Diabetes mellitus, SGLT inhibitors, dose-response
- 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.
LIK066Drug
Experimental treatment doses
SitagliptinDrug
Active comparator treatment dose
PlaceboDrug
Placebo comparator dose
| Study group | Role | What they receive |
|---|---|---|
| LIK066 2.5 mg | Experimental | Patients receive 2.5 mg of LIK066 once daily for 12 weeks Receives: Drug: LIK066 |
| LIK066 5 mg | Experimental | Patients receive 5 mg of LIK066 once daily for 12 weeks Receives: Drug: LIK066 |
| LIK066 10 mg | Experimental | Patients receive 10 mg of LIK066 once daily for 12 weeks Receives: Drug: LIK066 |
| LIK066 25 mg | Experimental | Patients receive 25 mg of LIK066 once daily for 12 weeks Receives: Drug: LIK066 |
| LIK066 50 mg | Experimental | Patients receive 50 mg of LIK066 once daily for 12 weeks Receives: Drug: LIK066 |
| LIK066 100 mg | Experimental | Patients receive 100 mg of LIK066 once daily for 12 weeks Receives: Drug: LIK066 |
| LIK066 150 mg | Experimental | Patients receive 150 mg of LIK066 once daily for 12 weeks Receives: Drug: LIK066 |
| Sitagliptin 100 mg | Active comparator | Patients receive 100 mg sitagliptin once daily for 12 weeks Receives: Drug: Sitagliptin |
| Placebo | Placebo comparator | Patients receive placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo
Measured: baseline, 12 weeks
Secondary outcomes (12)
Change from baseline in Fasting Plasma Glucose
The effect of LIK066 on fasting plasma glucose after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in urinary glucose to creatinine ratio
The effect of LIK066 on urinary glucose to creatinine ratio after 12 weeks of treatment will be evaluated
Measured: baseline, 12 weeks
Change from baseline in Body weight
The effect of LIK066 on change in body weight after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in Blood pressure
The effect of LIK066 on change in systolic and diastolic blood pressure after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in postprandial glucose during a meal test
The effect of LIK066 on change in postprandial glucose during a meal test after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in beta cell function during a meal test
The effect of LIK066 on change in beta cell function during a meal test after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in insulin secretion relative to glucose during a meal test
The effect of LIK066on change in insulin secretion relative to glucose during a meal test after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in oral glucose insulin sensitivity during a meal test
The effect of LIK066 on change in oral glucose insulin sensitivity during a meal test after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in glucagon-like peptide response during a meal test
The effect of LIK066 on change in glucagon-like peptide during a meal test after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Change from baseline in Peptide YY response during a meal test
The effect of LIK066 on change in peptide YY response during a meal test after 12 weeks of treatment will be evaluated.
Measured: baseline, 12 weeks
Number of patients with adverse events to assess safety and tolerability of LIK066
The safety and tolerability of 7 doses of LIK066 after 12 weeks of treatment will be evaluated with number of patients reported for total adverse events, serious adverse events and death.
Measured: 12 weeks
Change from baseline in renal threshold for glucose excretion
The effect of LIK066 on renal threshold for glucose excretion will be calculated from glucose values in an overnight urine collection
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824264
- Sponsor's protocol ID
- CLIK066A2202
- Other IDs
- 2012-005793-63
- Status last verified
- Apr 2014
- First submitted
- 1 Apr 2013
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Evaluate Change in HbA1c After 12 Weeks Monotherapy With 7 Doses of LIK066 Compared With Placebo or Sitagliptin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01824264
- Acronym / sponsor ID
- CLIK066A2202
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes mellitus, SGLT inhibitors, dose-response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 4 Apr 2013 (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 the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| LIK066 2.5 mg | Experimental | Drug: LIK066Patients receive 2.5 mg of LIK066 once daily for 12 weeks |
| LIK066 5 mg | Experimental | Drug: LIK066Patients receive 5 mg of LIK066 once daily for 12 weeks |
| LIK066 10 mg | Experimental | Drug: LIK066Patients receive 10 mg of LIK066 once daily for 12 weeks |
| LIK066 25 mg | Experimental | Drug: LIK066Patients receive 25 mg of LIK066 once daily for 12 weeks |
| LIK066 50 mg | Experimental | Drug: LIK066Patients receive 50 mg of LIK066 once daily for 12 weeks |
| LIK066 100 mg | Experimental | Drug: LIK066Patients receive 100 mg of LIK066 once daily for 12 weeks |
| LIK066 150 mg | Experimental | Drug: LIK066Patients receive 150 mg of LIK066 once daily for 12 weeks |
| Sitagliptin 100 mg | Active comparator | Drug: SitagliptinPatients receive 100 mg sitagliptin once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive placebo for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of T2DM by standard criteria
- Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
- Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1
- Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI)
- HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients
Key exclusion criteria (7 listed)
- FPG ≥270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1
- Insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
- History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
- Significant lab abnormalities such as TSH outside of normal range, UACR>300 mg/g creatinine, eGFR <60 ml/min/1.73m2, hemoglobin <12 g/L in men and <11 g/L in women, hematuria
- ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >470 msec for women
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 |
|---|---|---|
| LIK066Experimental treatment doses | Drug | LIK066 10 mg, LIK066 100 mg, LIK066 150 mg, LIK066 2.5 mg, LIK066 25 mg, LIK066 5 mg, LIK066 50 mg |
| SitagliptinActive comparator treatment dose | Drug | Sitagliptin 100 mg |
| PlaceboPlacebo comparator dose | Drug | Placebo |
Primary outcome
Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo
12 secondary outcomes
Change from baseline in Fasting Plasma Glucose
Time frame: baseline, 12 weeks
Change from baseline in urinary glucose to creatinine ratio
Time frame: baseline, 12 weeks
Change from baseline in Body weight
Time frame: baseline, 12 weeks
Change from baseline in Blood pressure
Time frame: baseline, 12 weeks
Change from baseline in postprandial glucose during a meal test
Time frame: baseline, 12 weeks
Change from baseline in beta cell function during a meal test
Time frame: baseline, 12 weeks
Change from baseline in insulin secretion relative to glucose during a meal test
Time frame: baseline, 12 weeks
Change from baseline in oral glucose insulin sensitivity during a meal test
Time frame: baseline, 12 weeks
Change from baseline in glucagon-like peptide response during a meal test
Time frame: baseline, 12 weeks
Change from baseline in Peptide YY response during a meal test
Time frame: baseline, 12 weeks
Number of patients with adverse events to assess safety and tolerability of LIK066
Time frame: 12 weeks
Change from baseline in renal threshold for glucose excretion
Time frame: baseline, 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIK066 and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals.
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 7 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: withdrawn, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 from baseline in glycated hemoglobin (HbA1c) after 12 weeks (time frame: baseline, 12 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 3 Apr 2014.