Type 2 Diabetes Mellitus
Conditions
Keywords
Symlin, Amylin, insulin, Humalog, Novolog, Apidra
Brief summary
This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.
Interventions
DRUGpramlintide acetate (Symlin)
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
DRUGrapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
subcutaneous injection, dosing based on titration guidelines
DRUGbasal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has a clinical diagnosis of type 2 diabetes mellitus * Has an HbA1c \>7.0% and ≤10.0% * Has a BMI of ≥25 kg/m\^2 and ≤50 kg/m\^2 * Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy
Exclusion criteria
* Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months * Requires the use of drugs that stimulate gastrointestinal motility * Has been previously treated with Symlin (or has participated in a Symlin clinical study) * Is currently being treated with any of the following medications: \*Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat \[Xenical®\] and sibutramine \[Meridia®\]); \*Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; \*Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide \[Reglan®\]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; \*Investigational medications * Has a history or presence of any of the following: \*Eating disorders (including anorexia and/or bulimia); \*Bariatric surgery (gastric bypass, gastric banding, or gastroplasty) * Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study * Has donated blood within 30 days of study start or plans to donate blood during the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia | 24 Weeks | A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving HbA1c <=7% at Week 24 | 24 Weeks | This is a component of the primary endpoint |
| Percentage of Patients With no Weight Gain at Week 24 | 24 Weeks | This is a component of the primary endpoint |
| Percentage of Patients With a Severe Hypoglycemia Adverse Event | 24 Weeks | This is a component of the primary endpoint. |
| Change in HbA1c From Baseline at Week 24 | From Baseline to Week 24 | Baseline values are presented in the Baseline Characteristics section |
| Change in Body Weight From Baseline at Week 24 | From Baseline to Week 24 | Baseline values are presented in the Baseline Characteristics section |
| Change in Fasting Plasma Glucose From Baseline at Week 24 | From Baseline to Week 24 | Baseline values are presented in the Baseline Characteristics section |
| Fasting Serum Lipids Change From Baseline to Week 24 | Baseline, week 24 | — |
| Phase 2: Change in HbA1c at Week 36 | Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 | Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only). |
| Phase 2: Change in Body Weight at Week 36 | Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 | Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only). |
| Change in Waist Circumference From Baseline at Week 24 | From Baseline to Week 24 | Baseline values are presented in the Baseline Characteristics section |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia Adverse Events | 36 weeks | MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating. MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion). SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A (Phase 1 SYMLIN) SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study | 56 |
| Group B (Phase 1 RA Insulin) Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study | 56 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Phase 1 (Randomized Population) | Adverse Event | 2 | 0 | 0 | 0 | 0 | 0 |
| Phase 1 (Randomized Population) | Investigator Decision | 1 | 0 | 0 | 0 | 0 | 0 |
| Phase 1 (Randomized Population) | Lost to Follow-up | 2 | 4 | 0 | 0 | 0 | 0 |
| Phase 1 (Randomized Population) | Withdrawal of Consent | 4 | 2 | 0 | 0 | 0 | 0 |
| Phase 2 (Intent-to-Treat Population) | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Phase 2 (Intent-to-Treat Population) | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 |
| Phase 2 (Intent-to-Treat Population) | Withdrawal of Consent | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Group A (Phase 1 SYMLIN) | Group B (Phase 1 RA Insulin) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 10 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants | 46 Participants | 49 Participants |
| Age, Continuous | 54.3 years STANDARD_DEVIATION 10.53 | 55.0 years STANDARD_DEVIATION 11.35 | 53.6 years STANDARD_DEVIATION 9.7 |
| Fasting Plasma Glucose | 159.7 mg/dL STANDARD_DEVIATION 44.92 | 155.1 mg/dL STANDARD_DEVIATION 39.6 | 164.3 mg/dL STANDARD_DEVIATION 49.61 |
| Fasting Serum Lipids HDL | 43.23 mg/dL STANDARD_DEVIATION 10.79 | 44.71 mg/dL STANDARD_DEVIATION 11.893 | 41.77 mg/dL STANDARD_DEVIATION 9.468 |
| Fasting Serum Lipids LDL | 89.78 mg/dL STANDARD_DEVIATION 36.133 | 89.15 mg/dL STANDARD_DEVIATION 38.386 | 90.41 mg/dL STANDARD_DEVIATION 34.114 |
| Fasting Serum Lipids Total Cholesterol | 168.70 mg/dL STANDARD_DEVIATION 47.903 | 167.53 mg/dL STANDARD_DEVIATION 47.054 | 169.86 mg/dL STANDARD_DEVIATION 49.121 |
| Fasting Serum Lipids Triglycerides | 183.95 mg/dL STANDARD_DEVIATION 136.273 | 174.13 mg/dL STANDARD_DEVIATION 108.257 | 193.59 mg/dL STANDARD_DEVIATION 159.508 |
| HbA1c | 8.22 Percent STANDARD_DEVIATION 0.825 | 8.19 Percent STANDARD_DEVIATION 0.84 | 8.25 Percent STANDARD_DEVIATION 0.816 |
| Region of Enrollment United States | 112 participants | 56 participants | 56 participants |
| Sex: Female, Male Female | 41 Participants | 22 Participants | 19 Participants |
| Sex: Female, Male Male | 71 Participants | 34 Participants | 37 Participants |
| Waist Circumference | 116.73 cm STANDARD_DEVIATION 14.297 | 116.31 cm STANDARD_DEVIATION 15.427 | 117.15 cm STANDARD_DEVIATION 13.198 |
| Weight | 105.67 kg STANDARD_DEVIATION 20.032 | 107.87 kg STANDARD_DEVIATION 21.893 | 103.46 kg STANDARD_DEVIATION 17.908 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 56 | 28 / 56 | 9 / 17 | 11 / 31 | 4 / 14 | 11 / 36 |
| serious Total, serious adverse events | 1 / 56 | 5 / 56 | 0 / 17 | 0 / 31 | 0 / 14 | 0 / 36 |
Outcome results
Primary
The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.
Time frame: 24 Weeks
Population: Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Phase 1 SYMLIN) | The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia | 30.4 Percent |
| Group B (Phase 1 RA Insulin) | The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia | 10.7 Percent |
p-value: 0.018Fisher Exact
Secondary
Change in Body Weight From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Population: Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Change in Body Weight From Baseline at Week 24 | 0.02 kg | Standard Error 0.68 |
| Group B (Phase 1 RA Insulin) | Change in Body Weight From Baseline at Week 24 | 4.65 kg | Standard Error 0.68 |
Secondary
Change in Fasting Plasma Glucose From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Population: Phase 1 Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Change in Fasting Plasma Glucose From Baseline at Week 24 | -29.0 mg/dL | Standard Error 7.32 |
| Group B (Phase 1 RA Insulin) | Change in Fasting Plasma Glucose From Baseline at Week 24 | -37.8 mg/dL | Standard Error 7.69 |
Secondary
Change in HbA1c From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Population: Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Change in HbA1c From Baseline at Week 24 | -1.11 Percent | Standard Error 0.17 |
| Group B (Phase 1 RA Insulin) | Change in HbA1c From Baseline at Week 24 | -1.27 Percent | Standard Error 0.17 |
Secondary
Change in Waist Circumference From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Time frame: From Baseline to Week 24
Population: Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Change in Waist Circumference From Baseline at Week 24 | -0.63 cm | Standard Error 0.87 |
| Group B (Phase 1 RA Insulin) | Change in Waist Circumference From Baseline at Week 24 | 2.17 cm | Standard Error 0.86 |
Secondary
Fasting Serum Lipids Change From Baseline to Week 24
Time frame: Baseline, week 24
Population: Phase 1 Intent-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Fasting Serum Lipids Change From Baseline to Week 24 | Total Cholesterol | -1.81 mg/dL | Standard Error 5.826 |
| Group A (Phase 1 SYMLIN) | Fasting Serum Lipids Change From Baseline to Week 24 | LDL | 2.36 mg/dL | Standard Error 4.456 |
| Group A (Phase 1 SYMLIN) | Fasting Serum Lipids Change From Baseline to Week 24 | HDL | 1.11 mg/dL | Standard Error 1.19 |
| Group A (Phase 1 SYMLIN) | Fasting Serum Lipids Change From Baseline to Week 24 | Triglycerides | -28.96 mg/dL | Standard Error 12.442 |
| Group B (Phase 1 RA Insulin) | Fasting Serum Lipids Change From Baseline to Week 24 | Triglycerides | -31.98 mg/dL | Standard Error 13.883 |
| Group B (Phase 1 RA Insulin) | Fasting Serum Lipids Change From Baseline to Week 24 | Total Cholesterol | 5.27 mg/dL | Standard Error 4.649 |
| Group B (Phase 1 RA Insulin) | Fasting Serum Lipids Change From Baseline to Week 24 | HDL | 1.65 mg/dL | Standard Error 1.075 |
| Group B (Phase 1 RA Insulin) | Fasting Serum Lipids Change From Baseline to Week 24 | LDL | 9.12 mg/dL | Standard Error 3.865 |
Secondary
Percentage of Patients Achieving HbA1c <=7% at Week 24
This is a component of the primary endpoint
Time frame: 24 Weeks
Population: Phase 1 Intent-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Phase 1 SYMLIN) | Percentage of Patients Achieving HbA1c <=7% at Week 24 | 44.6 Percent |
| Group B (Phase 1 RA Insulin) | Percentage of Patients Achieving HbA1c <=7% at Week 24 | 55.4 Percent |
Secondary
Percentage of Patients With a Severe Hypoglycemia Adverse Event
This is a component of the primary endpoint.
Time frame: 24 Weeks
Population: Phase 1 Intent-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Phase 1 SYMLIN) | Percentage of Patients With a Severe Hypoglycemia Adverse Event | 0.0 Percent |
| Group B (Phase 1 RA Insulin) | Percentage of Patients With a Severe Hypoglycemia Adverse Event | 0.0 Percent |
Secondary
Percentage of Patients With no Weight Gain at Week 24
This is a component of the primary endpoint
Time frame: 24 Weeks
Population: Phase 1 Intent-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Phase 1 SYMLIN) | Percentage of Patients With no Weight Gain at Week 24 | 46.4 Percent |
| Group B (Phase 1 RA Insulin) | Percentage of Patients With no Weight Gain at Week 24 | 14.3 Percent |
Secondary
Phase 2: Change in Body Weight at Week 36
Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
Time frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Population: Phase 2 Intent-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Phase 2 Baseline at Week 24 | 108.50 kg | Standard Error 5.656 |
| Group A (Phase 1 SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 2 Baseline to Week 36 | 0.69 kg | Standard Error 0.654 |
| Group A (Phase 1 SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Phase 1 Baseline | 109.98 kg | Standard Error 4.916 |
| Group A (Phase 1 SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 1 Baseline to Week 36 | -0.80 kg | Standard Error 2.096 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 2 Baseline to Week 36 | 0.50 kg | Standard Error 0.303 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 1 Baseline to Week 36 | 1.34 kg | Standard Error 0.933 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Phase 2 Baseline at Week 24 | 105.67 kg | Standard Error 4.045 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Phase 1 Baseline | 104.83 kg | Standard Error 3.959 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Phase 1 Baseline | 104.42 kg | Standard Error 7.341 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 1 Baseline to Week 36 | 3.90 kg | Standard Error 1.488 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Phase 2 Baseline at Week 24 | 107.87 kg | Standard Error 7.801 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 2 Baseline to Week 36 | 0.44 kg | Standard Error 0.518 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 1 Baseline to Week 36 | 4.51 kg | Standard Error 0.761 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Phase 2 Baseline at Week 24 | 110.68 kg | Standard Error 2.507 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Change From Phase 2 Baseline to Week 36 | -0.86 kg | Standard Error 0.353 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in Body Weight at Week 36 | Phase 1 Baseline | 105.30 kg | Standard Error 2.21 |
Secondary
Phase 2: Change in HbA1c at Week 36
Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
Time frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Population: Phase 2 Intent-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Phase 1 Baseline | 8.35 Percent | Standard Error 0.214 |
| Group A (Phase 1 SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 1 Baseline to Week 36 | -1.96 Percent | Standard Error 0.238 |
| Group A (Phase 1 SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Phase 2 Baseline at Week 24 | 6.26 Percent | Standard Error 0.121 |
| Group A (Phase 1 SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 2 Baseline to Week 36 | 0.14 Percent | Standard Error 0.062 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 1 Baseline to Week 36 | -0.68 Percent | Standard Error 0.174 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Phase 2 Baseline at Week 24 | 7.57 Percent | Standard Error 0.171 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 2 Baseline to Week 36 | -0.23 Percent | Standard Error 0.123 |
| Group B (Phase 1 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Phase 1 Baseline | 8.03 Percent | Standard Error 0.14 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Phase 2 Baseline at Week 24 | 6.14 Percent | Standard Error 0.107 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 1 Baseline to Week 36 | -1.49 Percent | Standard Error 0.189 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 2 Baseline to Week 36 | 0.22 Percent | Standard Error 0.097 |
| Group E (Phase 2 RA Insulin) | Phase 2: Change in HbA1c at Week 36 | Phase 1 Baseline | 7.85 Percent | Standard Error 0.183 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 2 Baseline to Week 36 | 0.07 Percent | Standard Error 0.113 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Change From Phase 1 Baseline to Week 36 | -0.99 Percent | Standard Error 0.157 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Phase 1 Baseline | 8.38 Percent | Standard Error 0.145 |
| Group F (Phase 2 RA Insulin + SYMLIN) | Phase 2: Change in HbA1c at Week 36 | Phase 2 Baseline at Week 24 | 7.32 Percent | Standard Error 0.17 |
Other Pre-specified
Hypoglycemia Adverse Events
MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating. MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion). SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.
Time frame: 36 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (Phase 1 SYMLIN) | Hypoglycemia Adverse Events | Mild | 31 participants |
| Group A (Phase 1 SYMLIN) | Hypoglycemia Adverse Events | Severe | 0 participants |
| Group A (Phase 1 SYMLIN) | Hypoglycemia Adverse Events | Moderate | 12 participants |
| Group B (Phase 1 RA Insulin) | Hypoglycemia Adverse Events | Severe | 0 participants |
| Group B (Phase 1 RA Insulin) | Hypoglycemia Adverse Events | Mild | 46 participants |
| Group B (Phase 1 RA Insulin) | Hypoglycemia Adverse Events | Moderate | 13 participants |
| Group E (Phase 2 RA Insulin) | Hypoglycemia Adverse Events | Moderate | 0 participants |
| Group E (Phase 2 RA Insulin) | Hypoglycemia Adverse Events | Severe | 0 participants |
| Group E (Phase 2 RA Insulin) | Hypoglycemia Adverse Events | Mild | 7 participants |
| Group F (Phase 2 RA Insulin + SYMLIN) | Hypoglycemia Adverse Events | Severe | 0 participants |
| Group F (Phase 2 RA Insulin + SYMLIN) | Hypoglycemia Adverse Events | Moderate | 1 participants |
| Group F (Phase 2 RA Insulin + SYMLIN) | Hypoglycemia Adverse Events | Mild | 18 participants |
| Group E (Phase 2 RA Insulin) | Hypoglycemia Adverse Events | Moderate | 2 participants |
| Group E (Phase 2 RA Insulin) | Hypoglycemia Adverse Events | Mild | 9 participants |
| Group E (Phase 2 RA Insulin) | Hypoglycemia Adverse Events | Severe | 0 participants |
| Group F (Phase 2 RA Insulin + SYMLIN) | Hypoglycemia Adverse Events | Severe | 0 participants |
| Group F (Phase 2 RA Insulin + SYMLIN) | Hypoglycemia Adverse Events | Moderate | 3 participants |
| Group F (Phase 2 RA Insulin + SYMLIN) | Hypoglycemia Adverse Events | Mild | 19 participants |