Phase 3
Completed N=206
Linagliptin Add-on to Insulin Background Therapy
Source: ClinicalTrials.gov NCT02897349 ↗Enrolled (actual)
206
Serious AEs
13.1%
Results posted
Jan 2020
Primary outcomePrimary: Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment — -0.20; -0.61 Percentage change — p=0.0016
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate the efficacy and safety of linagliptin compared to placebo when added on to insulin therapy alone or in combination with metformin in Chinese patients with type 2 diabetes mellitus with insufficient glycaemic control
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment |
-0.20; -0.61 | 0.0016 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment |
0.7; -5.5 | 0.2241 |
| SECONDARY Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment |
-0.06; -32.01 | 0.0001 sig |
| SECONDARY Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment |
8.2; 13.9 | 0.2431 |
| SECONDARY Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment |
3.0; 4.0 | 0.6235 |
| SECONDARY Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment |
36.0; 55.4 | 0.0049 sig |
| SECONDARY Percentage of Participants With Any Investigator-defined Hypoglycaemic Adverse Event (AE) With Plasma Glucose (PG) ≤70 mg/dL |
7.8; 10.6 | — |
| SECONDARY Percentage of Participants With Any Severe Hypoglycaemic AE |
0.0; 0.0 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus prior to informed consent.
- Chinese male or female patients who are pre-treated with insulin alone or in combination with metformin:
- With maximum insulin dose of = 7.5 % to = 18 years at Visit 1.
- BMI 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
- Any other antidiabetic drug within 3 months prior to informed consent except those defined as background treatment via inclusion criterion 2.
- Acute coronary syndrome (non-STEMI (ST Segment Elevation Myocardial Infarction), STEMI and unstable angina pectoris), stroke or TIA (Transient ischemic attack) within 3 months prior to informed consent.
- Indication of liver disease, defined by serum levels of either ALT (Alanine aminotransferase) (SGPT (serum glutamic pyruvate transaminase )), AST (Aspartate aminotransferase) (SGOT (serum glutamic-oxaloacetic transaminase)), or alkaline phosphatase above 3 × upper limit of normal (ULN (upper limit of normal)) as determined during screening and/or run-in phase.
- Any contraindications to metformin according to the local label for those patients that enter the study with metformin therapy as provided in ISF (Investigator Site File).
- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
- Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia).
- Known hypersensitivity or allergy to the investigational product or its recipients.
- Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
- Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM (Type 2 diabetes mellitus).
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
- Participation in another trial with an investigational drug within 2 months prior to informed consent or previous enrolment in this trial.
- Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial in the opinion of the investigator.
Data sourced from ClinicalTrials.gov (NCT02897349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.