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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
| Hillerod Hospital, Denmark | OTHER |
| Frederiksberg University Hospital | OTHER |
| University Hospital, Gentofte, Copenhagen |
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Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1M | Experimental | Metformin + Levemir x1 |
|
| 1P | Placebo Comparator | Placebo + Levemir x1 |
|
| 2M | Experimental | metformin + NovoMix |
|
| 2P | Placebo Comparator | Placebo + NovoMix |
|
| 3M | Experimental | Metformin + 4x therapy |
|
| 3P | Placebo Comparator | Placebo + 4x therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | metformin tablets 2 g x 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carotid intima media thickness | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Almdal, MD DMSc | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36923108 | Derived | Olsen MH, Almdal TP, Madsbad S, Ovesen C, Gluud C, Sneppen SB, Breum L, Hedetoft C, Krarup T, Lundby-Christensen L, Mathiesen ER, Roder ME, Vestergaard H, Wiinberg N, Jakobsen JC. Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial - A detailed statistical analysis plan. Contemp Clin Trials Commun. 2023 Feb 24;33:101095. doi: 10.1016/j.conctc.2023.101095. eCollection 2023 Jun. | |
| 32979921 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069057 | Insulin Detemir |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 |
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| OTHER |
| Rigshospitalet, Denmark | OTHER |
| Bispebjerg Hospital | OTHER |
| Herlev Hospital | OTHER |
| Zealand University Hospital | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| Novo Nordisk A/S | INDUSTRY |
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| insulin detemir | Drug | insulin as requested |
|
|
| insulin aspart + insulin aspart protamin | Drug | insulin as requested |
|
|
| Insulin aspart | Drug | insulin as requested |
|
|
| Copenhagen |
| 2400 |
| Denmark |
| Frederiksberg Hospital | Frederiksberg | 2000 | Denmark |
| Gentofte Sygehus | Gentofte Municipality | 2820 | Denmark |
| Steno Diabetes Center | Gentofte Municipality | 2820 | Denmark |
| Herlev Hospital | Herlev | 2830 | Denmark |
| Hillerod Sygehus | Hillerød | 3400 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Køge Sygehus | Køge | 4600 | Denmark |
| Derived |
| Hansen CS, Lundby-Christiansen L, Tarnow L, Gluud C, Hedetoft C, Thorsteinsson B, Hemmingsen B, Wiinberg N, Sneppen SB, Lund SS, Krarup T, Madsbad S, Almdal T, Carstensen B, Jorgensen ME; CIMT study group. Metformin may adversely affect orthostatic blood pressure recovery in patients with type 2 diabetes: substudy from the placebo-controlled Copenhagen Insulin and Metformin Therapy (CIMT) trial. Cardiovasc Diabetol. 2020 Sep 26;19(1):150. doi: 10.1186/s12933-020-01131-3. |
| 30027438 | Derived | Nordklint AK, Almdal TP, Vestergaard P, Lundby-Christensen L, Boesgaard TW, Breum L, Gade-Rasmussen B, Sneppen SB, Gluud C, Hemmingsen B, Jensen T, Krarup T, Madsbad S, Mathiesen ER, Perrild H, Tarnow L, Thorsteinsson B, Vestergaard H, Lund SS, Eiken P. The effect of metformin versus placebo in combination with insulin analogues on bone mineral density and trabecular bone score in patients with type 2 diabetes mellitus: a randomized placebo-controlled trial. Osteoporos Int. 2018 Nov;29(11):2517-2526. doi: 10.1007/s00198-018-4637-z. Epub 2018 Jul 19. |
| 26916685 | Derived | Lundby-Christensen L, Vaag A, Tarnow L, Almdal TP, Lund SS, Wetterslev J, Gluud C, Boesgaard TW, Wiinberg N, Perrild H, Krarup T, Snorgaard O, Gade-Rasmussen B, Thorsteinsson B, Roder M, Mathiesen ER, Jensen T, Vestergaard H, Hedetoft C, Breum L, Duun E, Sneppen SB, Pedersen O, Hemmingsen B, Carstensen B, Madsbad S. Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial. BMJ Open. 2016 Feb 25;6(2):e008377. doi: 10.1136/bmjopen-2015-008377. |
| 26916684 | Derived | Lundby-Christensen L, Tarnow L, Boesgaard TW, Lund SS, Wiinberg N, Perrild H, Krarup T, Snorgaard O, Gade-Rasmussen B, Thorsteinsson B, Roder M, Mathiesen ER, Jensen T, Vestergaard H, Hedetoft C, Breum L, Duun E, Sneppen SB, Pedersen O, Hemmingsen B, Carstensen B, Madsbad S, Gluud C, Wetterslev J, Vaag A, Almdal TP. Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial. BMJ Open. 2016 Feb 25;6(2):e008376. doi: 10.1136/bmjopen-2015-008376. |
| D004700 | Endocrine System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006946 | Hyperinsulinism |
| 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 |
| D061266 | Insulin, Short-Acting |