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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002716-16 | EudraCT Number | ||
| U1111-1158-3620 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral insulin 338 and subcutaneous placebo | Experimental |
| |
| Subcutaneous insulin glargine and oral placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin 338 (GIPET I) | Drug | Oral administered once daily in combination with metformin with or without DPP-4 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma glucose (FPG) | Week 0, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 10-points plasma glucose profile | Week 0, Week 8 | |
| Number of treatment emergent hypoglycaemic episodes | From start of treatment until Visit 14 (Day 68) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mainz | 55116 | Germany | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30679095 | Result | Halberg IB, Lyby K, Wassermann K, Heise T, Zijlstra E, Plum-Morschel L. Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial. Lancet Diabetes Endocrinol. 2019 Mar;7(3):179-188. doi: 10.1016/S2213-8587(18)30372-3. Epub 2019 Jan 21. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin glargine | Drug | Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor |
|
| placebo | Drug | Administered once daily |
|
| area under the serum insulin concentration-time curve |
| During one dosing interval (0 to 24 hours) at steady state (Day 56) |
| Neuss |
| 41460 |
| Germany |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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