Trial · NCT01915849
Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
NCT01915849, Phase 1, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus. Trials, record NCT01915849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01915849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
- NCT number
- NCT01915849
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- LIK066, Placebo
- First posted
- 2013-08-05
- Last updated
- 2015-02-06
- Results first posted
- 2015-02-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4) | Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4) | The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. | (umol/kg FFM/min)*hr | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | LIK066 15 mg | Day 1 | 101.97 | Standard Deviation 29.348 | (umol/kg FFM/min)*hr |
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | LIK066 50 mg | Day 1 | 93.89 | Standard Deviation 25.852 | (umol/kg FFM/min)*hr |
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | LIK066 150 mg | Day 1 | 63.84 | Standard Deviation 22.589 | (umol/kg FFM/min)*hr |
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | Placebo | Day 1 | 97.76 | Standard Deviation 30.615 | (umol/kg FFM/min)*hr |
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | LIK066 15 mg | Day 4 | 109.99 | Standard Deviation 27.144 | (umol/kg FFM/min)*hr |
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | LIK066 50 mg | Day 4 | 117.81 | Standard Deviation 30.881 | (umol/kg FFM/min)*hr |
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | LIK066 150 mg | Day 4 | 112.45 | Standard Deviation 31.129 | (umol/kg FFM/min)*hr |
| Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose | Placebo | Day 4 | 103.97 | Standard Deviation 23.335 | (umol/kg FFM/min)*hr |
Source ClinicalTrials.gov
Participant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (4 Days) | STARTED | Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg | 5 | |
| Treatment Period 1 (4 Days) | STARTED | Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo | 3 | |
| Treatment Period 1 (4 Days) | STARTED | Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg | 3 | |
| Treatment Period 1 (4 Days) | STARTED | Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg | 3 | |
| Treatment Period 1 (4 Days) | COMPLETED | Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg | 3 | |
| Treatment Period 1 (4 Days) | COMPLETED | Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo | 3 | |
| Treatment Period 1 (4 Days) | COMPLETED | Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg | 3 | |
| Treatment Period 1 (4 Days) | COMPLETED | Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg | 3 | |
| Treatment Period 1 (4 Days) | NOT COMPLETED | Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg | 2 | |
| Treatment Period 1 (4 Days) | NOT COMPLETED | Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 15 mg | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 50 mg | 1 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 150 mg | 0 | 12 | |
| other | Vision blurred | Eye disorders | Placebo | 1 | 12 | |
| other | Vision blurred | Eye disorders | LIK066 15 mg | 0 | 14 | |
| other | Vision blurred | Eye disorders | LIK066 50 mg | 0 | 12 | |
| other | Vision blurred | Eye disorders | LIK066 150 mg | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | LIK066 15 mg | 0 | 14 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | LIK066 15 mg | ||
| Total, all-cause mortality | LIK066 50 mg | ||
| Total, all-cause mortality | LIK066 150 mg | ||
| Total, other adverse events | Placebo | 5 | 12 |
| Total, other adverse events | LIK066 15 mg | 8 | 14 |
| Total, other adverse events | LIK066 50 mg | 7 | 12 |
| Total, other adverse events | LIK066 150 mg | 11 | 12 |
| Total, serious adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | LIK066 15 mg | 0 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01915849
GET https://conductscience.org/api/trials/v1/NCT01915849/flow?page=2